Careers

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking an Enviormental, Health & Safety Specialist to join our growing team. This role assists with planning, establishing, implementing, and maintaining a variety of occupational health, safety, and environmental programs and initiatives to assure the highest possible degree of health and safety for employees. This role assures that TriLink complies with applicable federal, state, and local health, safety, and environmental laws, regulations, and standards.

Responsibilities

• Identify and evaluate hazardous conditions and practices in the workplace.  Survey to identify and evaluate occupational health, safety, and environmental conditions.  Conduct and coordinate on-site inspections to audit physical conditions and safe work practices. 
• Assist with the implementation of controls from results of hazard analyses.  Measure and evaluate the effectiveness of the hazard control system, policies, and procedures, and recommend changes to minimize workplace injuries and illnesses.
• Assist in the development of education and training materials.  Conduct safety and environmental training to communicate hazard control information.  Assist in new employee occupational health, safety, and environmental orientation.
• Compile, analyze, interpret, and report accident, loss, and exposure statistical data; prepare recommendations for corrective action to eliminate or minimize risk. 
• Incorporate essential occupational health, safety, and environmental requirements in all purchasing and control actions.  Recommend the purchase of safety equipment and supplies.
• Perform other related duties as directed that correspond to the overall function of this position.
• This position assumes and performs other duties as assigned.

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.
TriLink BioTechnologies, a Maravai LifeSciences company, is seeking an Enviormental, Health & Safety Specialist to join our growing team. This role assists with planning, establishing, implementing, and maintaining a variety of occupational health, safety, and environmental programs and initiatives to assure the highest possible degree of health and safety for employees.  This role assures that TriLink complies with applicable federal, state, and local health, safety, and environmental laws, regulations, and standards.

Qualifications

• BA/BS or AD degree in Safety Engineering, Industrial Hygiene, or Environmental Sciences, or in a related field is preferred
• Must have thorough knowledge of applicable government regulations and computer skills (i.e. Word, Excel, Power Point)
• Demonstrates effective communication skills
• Capable of managing multiple projects in a fast-paced work environment
• Strong training and interpersonal skills
• Exhibits positivity, passion, integrity, and responsibility

Education

• BA/BS or AD degree in Safety Engineering, Industrial Hygiene, or Environmental Sciences, or in a related field is preferred

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a dynamic, fast-paced Customer Service Representative. This person will interact with customers and employees at all levels. This role will have responsibility for a wide range of customer service, order management, and other support functions. The Customer Service Representative will provide customer service in a responsive, empathetic, reliable, patient, resourceful, and assured manner.

Responsibilities

• Provide a sophisticated level of customer service
• Provide clear communications with customers and internal teams to ensure efficient execution of order fulfillment. Respond to and own all inbound requests, by email and phone, fulfilling requests in a friendly, professional, and timely manner
• Assist with customer complaints, order placement, errors, account questions, billing, and other inquiries

Qualifications

• Proven customer support experience
• Professional communication proficiency
• Attention to detail
• Problem-solving/critical thinking
• Strong multi-tasking abilities to complete activities in a fast-paced, deadline-driven environment
• Results-driven self-starter
• Ability to manage stress and maintain composure

Education

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Director, Business Development, Mid-Atlantic to join our growing team. This role will drive core and custom product revenue via direct client interactions to support the company’s growth objectives. Foster collaborations with KOLs to develop and nurture key/strategic accounts towards GMP relationships. Work with GMP team to develop project plans, MSA's, and other customer logistics as required. Successful performance increases revenue in core products and customer types likely to transition into GMP opportunities.

Responsibilities

• Act as a sales and marketing driver for the TriLink BioTechnologies business by identifying, developing and implementing key business development activities to exceed revenue goals.
• Optimize Trilink client focused activities within the designated territory by providing account strategy and leadership to the commercial teams to create valuable partnerships.
• Develop high level, strategic relationships to develop new OEM, diagnostic, life science and therapeutic strategic accounts, select and actively drive key accounts toward the GMP offering
• Deliver accurate assessment of opportunities and precise forecasting of sales. Develop deep knowledge of GMP clients or prospects within the region to ensure exposure to the Trilink offering early in the company life cycle by attending regional networking events and conferences.
• Actively contribute Voice of Customer (VOC) to the development of marketing strategies and tactics.
• Identify opportunities for targeted educational and market interaction activities / events within the region and work with internal team to insure measurable positive results.
• Utilize appropriate internal resources to address client issues and move revenue opportunities forward.
• Professionally and proactively communicate with external and internal customers. Work with internal teams to create customer facing documents (contracts, supply agreements, etc.) of the highest professional level and accuracy.
• Other duties, as assigned.

Qualifications

• Degree in Biology, Cellular Biology, Molecular Biology, Genomics, Biochemistry or related discipline Advanced degree is a plus.
• Minimum 5 years of commercial experience in Molecular Biology, Genomics and/or Biologic CMO sales and/or business development.
• Demonstrated advancement within organizations with increasing responsibilities.
• Proven track record of demonstrated success in a broad range of areas including, but not limited to business development, marketing and sales.
• Excellent computer software skills with demonstrable expertise in Excel, Word, PowerPoint, and Salesforce.com.
• Proficiency with verbal and written communication in English. Strong presentation skills required.
• Working language proficiency in French, German, Spanish, Italian, or Chinese is not required but would be a plus.
• Excellent organizational, analytical, strategic, and interpersonal skills.
• Travel up to 50% of the time to support sales, business development activities, conferences and training. Includes regular visits to the TriLink offices in San Diego.
• Ability to work independtly in a home office.
• Location: Washington, D.C. area, Mid-Atlantic
• Occasional lifting of marketing and trade show materials of up to 40 lbs.

Education

• Degree in Biology, Cellular Biology, Molecular Biology, Genomics, Biochemistry or related discipline Advanced degree is a plus.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Director of Engineering. As part of the Senior Leadership team at TriLink, this individual will oversee Facility, Equipment, and Process Engineering, Automation Engineering, Capital and Engineering Project Management, as well as Maintenance, Calibration, and new equipment Validation. The leader will ensure GMP operations and enforce ISO practices in Engineering Operations, manage budgets, oversee routine maintenance and calibrations programs, oversee site risk management, and ensure proper facility operation and expansion. This role will work closely with Manufacturing, Quality, R&D, PD, and IT on strategic projects including M&A, TriLink capital management, computer systems/ controls, maintain site facility, assist with growth and layout strategy, to include strategic facilities requirements support new product and process development

Responsibilities

• Provide stable and effective leadership, support, and direction to the engineering team, creating an organization dedicated to innovation, effectiveness, safety, and flexibility
• Participate and lead, when required, key strategic initiatives, including facilities planning and M&A/integration. Work with key senior leadership and outside resources/consultants to achieve corporate goals
• Hire and retain key talent to meet strategic and tactical goals and KPI’s
• Develop policies and oversee key routine maintenance, calibration, validation, and repairs
• Oversee security and conduct site inspections. Respond to emergencies as needed
• Work with senior leadership to identify opportunities to reduce operating costs, enhance margins and improve production efficiencies
• Ensure compliance with federal, state, and local regulations and laws

Qualifications

• Required BS Engineering
• 12+ years of increasingly responsible engineering, automation, maintenance, and validation operations in an ISO or GMP operational environment
• Experience as a cross-functional leader with demonstrated results in building out facilities to support new product and process introductions
• Ability to establish and lead the Site Capital Committee inclusive of the development of site operational capital budget to support a total site engineering solution
• Knowledge of construction with an emphasis on understanding ISO and GMP requirements for manufacturing raw materials, API (Drug Substance), and Diagnostic products.
• Knowledge of budgeting and accounting practices
• Ability to establish and maintain effective working relationships with those contacted in the course of work
• Ability to maintain awareness of new and changing techniques and technology in facility and equipment systems
• Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
• Strong multi-tasking abilities to complete activities in a fast-paced, deadline-driven environment
• Results-driven self-starter
• Ability to manage stress and balance competing demands in a high throughput environment

Education

• Required BS Engineering

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Document Control Specialist responsible for maintaining the document and record control systems to meet Quality Management System requirements. Responsible for coordinating the issuance, revision, review, and approval of SOPs and other documents.

Responsibilities

• Issuance of document change control numbers, routing and tracking of new and revised documents for approval, filing of controlled documents and other documentation provided to QA, and ensuring that all documents follow the change control procedure
• Review of documents for completeness, adherence to company guidelines for formatting, review of authorization for approvals
• Monitoring of status of in-process document changes to ensure timely completion
• Organization of filing systems for electronic and paper-based GMP/Research documents
• Review and filing of Raw Material Inspection and Release forms
• Assisting in internal audits
• Maintain training program management, including training plans, assigning training, user set-up, input of paper records into electronic system, etc.
• Support the establishment and improvement of quality systems and facilitate continuous improvements efforts of the Quality System
• Assist in quality audits, including document preparation and record retrieval
• Update and maintain quality metrics as needed

Qualifications

• BS Degree in scientific area preferred
• Quality professional with a minimum of 5 years of hands on experience with document control management, preferably in a life science industry
• Experience with ISO 9001, ISO 13485, 21CFR820, 21CFR 211, or other regulated industry a plus
• Experience with MasterControl or other document management system a plus but not required
• Good writing skills, high degree of organization and excellent attention to detail
• The successful candidate will also demonstrate an ability to work independently and as part of a team. Working within the team is essential to success in this position.
• Good computer skills with working knowledge of MS office suite and Adobe Acrobat
• Self-motivated and able to organize and prioritize multiple tasks
• Must be able to support after hours and weekends as needed

Education

• BS Degree in scientific area preferred

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Facilities Technician to join our growing team. Responsibilities include general building repair & maintenance, installation, repair, and maintenance of furniture/fixtures/equipment in both lab and office areas, and special projects as assigned to support the team.

Responsibilities

• Respond to organizational help desk requests in a timely manner while providing a high level of customer service, communication, and support.
• Perform routine repair, maintenance, and installation of furniture, fixtures, and equipment in both lab and office environments.
• •Responsible for special projects assigned to support relocations/reconfigurations, storage/inventory, set up of new services.
• Prepare and execute internal employee and lab relocations
• Perform work in one or more maintenance trades, including carpentry, electrical, plumbing, painting, lighting, etc.
• Assist with the logistics and set up for corporate events and conference rooms
• Perform daily, weekly building walks to monitor the general operation, safety, and condition of the facility. Proactively communicate, plan, and implement solutions in conjunction with the operations team to resolve findings.

Qualifications

• Minimum 3 years experience as a facilities technician or related work within the biotech industry
• Proficient in basic HVAC, electrical, and plumbing, painting/drywall, lighting and ballast replacement
• Proficient in furniture repair, installation, and ergonomics
• Experience working in a GMP environment and completion of GMP documentation
• OSHA safe work practices
• Knowledgeable in general, fire prevention, electrical, hazardous material, and laboratory safety
• Knowledgeable of maintenance and environmental standards
• Good troubleshooting skills – mechanical / electrical / plumbing
• Comply with Good Documentation Practices
• Good communication and organizational skills
• Must have basic computer skills to include Microsoft Office
• Thrive in a fast-paced environment and is skilled at multi-tasking
• Reliable and meets all required deadlines
• Must be able to lift 50 pounds
• Exposure to elements (i.e. hot weather, cold weather, precipitation) for brief periods.
• Operate computer-controlled equipment which requires a combination of standing, sitting, and walking to and from the operator interface terminal
• Required to work around live electrical circuits and mechanical devices in the execution of their duties

Education

• Minimum 3 years experience as a facilities technician or related work within the biotech industry

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking an Industrial Hygienist to join our growing team. The role of our Industrial Hygienist is to assess health risks within the workplace, and devise strategies to reduce the effects on employee health and well-being. This role requires a balance of analytical skills and leadership, will work closely with management to provide reports and make recommendations to improve environmental, health and safety of the workplace.

The Industrial Hygienist will manage TriLink’s COVID-19 Exposure Control Program by assessing and enforcing COVID-19 health and safety protocols and procedures. This individual will work closely with all levels of the organization to provide guidance and support on the execution of COVID-19 health and safety protocols including testing and contact tracing.

Responsibilities

• Manage COVID-19 related administration, education, testing vendor, tracing, and employee communication program in place to support a safe work environment.
• Review current policies, protocols, procedures, and guidelines for best practices considering the circumstances and provide guidance on required revisions and updates from time to time as COVID-19 infectious disease guidance evolves.
• Responsible for the oversight, management, and leadership of the on-site COVID-19 task force.
• Oversee and monitor social/physical distancing, symptom monitoring, disinfecting protocols, etc.
• Monitor the testing protocols established to ensure compliance and that notification protocols are being followed.
• Identify COVID-19 hazards in the workplace; provide guidance on ways to reduce and prevent infections disease exposures on the job.
• Provide recommendations for tasks that can be potentially hazardous to workers.
• Conduct periodic inspections of the workplace to ensure that COVID-19 infectious disease protocols and procedures are being operationalized.
• Support with planning on all Health and Safety requirements.
• Gather environmental data and use a variety of methodologies to gather environmental readings and may also speak to workers about their health and well-being.
• Analyze the environmental data they gather to identify potential health and safety risks within the workplace. This process can involve developing a hypothesis about employee health issues and testing environmental samples to determine the causes behind them or using data analysis methodologies to identify current and potential risk factors. May also consult government guidelines as they develop assessments.
• Develop strategies to reduce and eliminate health and wellness risks within the workplace.
• Develop educational materials and programs to support employee health and wellness.
• Provide consulting and advice to management on integrating the solution without interrupting workplace functionality. In this aspect of the role, the industrial hygienist may develop short-term strategies that help mitigate the issue while keeping costs to a minimum. presentations related to new standards for industrial hygiene and occupational safety hazards.

Qualifications

• Bachelors’ degree in a related field such as: industrial hygiene, environmental science, chemistry, or engineering
• 5+ years of professional experience
• Preferably certified through the American Board of Industrial Hygiene (ABIH)
• Knowledgeable about environmental and occupational hazards and should be able to quickly identify problems related to air quality, chemical laboratory and other environmental factors
• Strong analytical skills to assess issues and develop working hypotheses about the causes of environmental and occupational health issues
• Attentive and able to notice, measure, and monitor slight changes that can impact workers’ health and wellness
• Effective written and verbal communicators to prepare reports related to their findings and solutions and collaborate with medical professionals and supervisors
• Primary functions require sufficient physical ability and mobility to work in a classroom setting; to stand or sit for prolonged periods of time; to occasionally stoop, bend, kneel, crouch, reach, and twist; to lift, carry, push, and/or pull light to moderate amounts of weight; to operate office equipment requiring repetitive hand movement and fine coordination including use of a computer keyboard; and to verbally communicate to exchange information.

Education

• Bachelors’ degree in a related field such as: industrial hygiene, environmental science, chemistry, or engineering

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is Maravai LifeSciences company is looking for a IT Support Specialist. The It tech provide support for Executives and basic user problems. Answer any questions relating to laptops/workstations, printers, peripherals, mobile devices, IT related software, email, communications, etc. Basic skills of active directory. Familiar with Office 365.

Responsibilities

• Responsible for the Executive/Desktop support
• Updates asset and inventory list
• Assists with onboarding of new employees
• Reviews, prioritizes, and responds to Helpdesk tickets
• Manages multiple projects simultaneously while maintaining high customer service standards
• Considered a Subject Matter Expert (SME) for TriLink’s IT Team
• Perform other duties and responsibilities as assigned.

Qualifications

• Required experience with Apple products supporting Executives
• Required experience with troubleshooting common IT problems
• Outstanding interpersonal skills and excellent written verbal communication
• Ability to multi-task and prioritize workload, while maintaining efficiency and quality of work
• Able to troubleshoot hardware issues and repair systems
• Familiarity with working in a lab environment

Education

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Manufacturing Associate II. The Manufacturing Associate will produce research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; utilizing pilot grade purification systems, authoring and implementing SOPs, and documenting actions in batch records.

Responsibilities

• Prepares for production by reviewing production schedules; reviewing specifications; calculating requirements; assembling materials and supplies
• Performs dilutions and spectrophotometric readings to quantify compounds
• Operates and maintains rotary evaporator to concentrate compounds
• Operates and maintains HPLC/UPLC equipment for purification and analytical QC
• Performs wet chemistry reactions, primarily phosphorylation chemistry
• Maintains a safe and clean work environment
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices
• Preforms projects based on process improvements and scale-up
• Performs characterization assays centered around developmental improvements
• Onboards and authors procedures for new equipment
• Transfers developmental improvements to manufacturing team through training/technical transfer

Qualifications

• A Bachelor of Science in a scientific field, preferably in Chemistry or Biochemistry.
• At least 3-5 years of relevant manufacturing laboratory experience with a preferred emphasis on HPLC purification of small molecules and/or small molecule synthesis.
• Experience with drafting, editing, implementing, and executing Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to mentor and train other team members on processes they have become proficient at executing

Education

• A Bachelor of Science in a scientific field, preferably in Chemistry or Biochemistry.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Manufacturing Associate II. The Manufacturing Associate will produces research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; utilizing pilot grade purification systems, authoring and implementing SOPs, and documenting actions in batch records.

Responsibilities

• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies.
• Maintains safe and clean work environment by following standard operating procedures.
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices.
• Trains and mentors new team members.
• Onboards new equipment with minimal supervision
• Identifies key process bottlenecks and implements process improvements to minimize bottleneck.
• Updates job knowledge by participating in training opportunities.

Qualifications

• A Bachelor of Science in a scientific field, preferably in Chemistry or Biochemistry.
• At least 3-5 years of relevant manufacturing laboratory experience with a preferred emphasis on HPLC purification of small molecules and/or small molecule synthesis.
• Experience with drafting, editing, implementing, and executing Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to mentor and train other team members on processes they have become proficient at executing

Education

• A Bachelor of Science in a scientific field, preferably in Chemistry or Biochemistry.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Manufacturing Associate II, GMP Reagents to join our growing team. This role produces research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; utlizing pilot grade purifiation systems, authoring and implementing SOPs, and documenting action in batch records.

This role will cover the shift from 3 p.m. to Midnight.

Responsibilities

• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies
• Maintains safe and clean work environment by following standard operating procedures
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices
• Trains and mentors new team members
• Onboards new equipment with minimal supervision
• Identifies key process bottlenecks and implements process improvements to minimize bottleneck
• Updates job knowledge by participating in training opportunities

Qualifications

• Bachelor’s of Science in a scientific field, preferably Chemistry or Biochemistry
• At least 3-5 years of relevant manufacturing laboratory experience with a preferred emphasis on HPLC purification of small molecules and/or small molecule synthesis
• Experience with drafting, editing, implementing, and executing Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to mentor and train other team members on processes they have become proficient at executing

Education

• Bachelor’s of Science in a scientific field, preferably Chemistry or Biochemistry

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Manufacturing Associate II, Plasmid to join our growing team. This position will produce research and clinical grade components and products within ISO 8 and greater environments. The candidate will participate in the set-up, cleaning, operation, and maintenance of laboratory equipment; perform chemical and enzymatic reactions following aseptic procedures. The candidate must document all actions using Good Documentation Practices. This position requires someone who can perform as a leader in the laboratory.

Responsibilities

• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies
• Provides written and verbal updates to supervisors or other department managers
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements
• Prepares production areas for cGMP project initiation or changeover
• Writes and executes batch records, author and review SOP’s, and maintain quality documents associated with manufacturing
• Trains other manufacturing personnel
• Participates in the maintenance and overall cleanliness of the workspace
• Keeps equipment operating by following operating instructions and troubleshooting breakdowns
• Interfaces with manufacturing support groups to align on production requirements
• Performs as a leader in the laboratory space

Qualifications

• BS degree or equivalent in life sciences or related field
• Minimum of 3 years of experience working in a professional lab
• Experience with plasmid DNA manufacturing processes desired
• Experience in a cGMP clean room environment preferred
• Excellent written and verbal communication skills
• Solid organizational skills, detail-orientation, and demonstrated problem-solving abilities
• Self-starter, able to organize and prioritize multiple tasks

Education

• BS degree or equivalent in life sciences or related field

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Manufacturing Engineering Technician. This role will provide support for daily sustaining efforts in a high throughput manufacturing environment. This position will troubleshoot issues, coordinate, and perform preventative maintenance on mechanical, electrical, and fluidics systems within a quality system. The ideal candidate will apply organic chemistry principles in troubleshooting manufacturing and equipment process issues.

Responsibilities

• Coordinate scheduling between manufacturing and vendors to ensure preventative and unplanned maintenance is completed
• Operates and performs troubleshooting activities in compliance with the quality system
• Collects and audits data to maintain the engineering maintenance database
• Perform documented and undocumented maintenance activities
• Troubleshoots mechanical, electrical, pneumatic, fluidic, and optical equipment systems with minimal guidance
• Schedules maintenance and support with vendors
• Make suggestions for continuous improvement and cost savings
• Collaborates with other groups cross-functionally to manage support to achieve production goals
• Manage spare parts and lab supplies to support production areas
• Work with a team and individually to solve complex problems
• Execute multiple assigned activities in parallel to support production and engineering improvements

Qualifications

• Requires a High School or Associate Degree
• Typically requires a minimum of 1-3 years of experience in a manufacturing setting - Pharma, Semiconductor or GMP Experience is a plus
• Familiar with reading and interpreting vendor documentation as well as schematics
• Strong organizational skills needed
• Ability to use PC with Microsoft Office products (Outlook, Excel, Word, etc.)
• Flexibility to work a shift as defined by manufacturing schedules
• TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

Education

• Requires a High School or Associate Degree

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is looking for a Planner to join their growing team. This role will support planning, forecasting, finite scheduling, and schedule adherence to meet long-term growth and profitability targets. Serve as point of contact for daily execution within the organization and work closely with Manufacturing, Operations, Quality, R&D, and Commercial. Sustain production to help us take the next steps forward in our high-growth cycle.

Responsibilities

• Responsible for ensuring daily raw materials and finished goods needs are known and secured through collaboration with Manufacturing, Quality, Procurement, and Materials Management
• Plan and manage long-term production schedules to meet customer requirements, and best utilize manufacturing capability
• Analyze customer orders, market forecasts, and trend analysis to ensure the resources, capacity, and flow path can meet demands
• Monitor and adjust daily, weekly, and monthly schedules based upon production and sales performance
• Analyze work order releases with respect to capacity planning and material requirements
• Provide guidance and trending information to buyers to optimize the stock position of raw materials
• Participate in the development of a high performing culture focused on critical KPI’s such as Revenue, On-Time Delivery (OTD), Schedule Adherence, and Quality/First Time Pass
• Review and plan requirements for acceptable inventory, find and evaluate raw material supply sources, coordinate procurement efforts, and determine the level of need for the procured items
• Creation of new items, BOMs, work orders, etc
• Perform other related duties as required or assigned

Qualifications

• Associates Degree required BS preferred in business, engineering, life sciences, or a related field
• 2+ years of experience planning in a manufacturing environment
• Experience with ERP/MRP systems, such as NetSuite and Microsoft Office products
• CPIM/APICS certification strongly preferred
• Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
• Self-motivated and able to organize and prioritize multiple tasks
• Excellent written and verbal communication skills
• Ability to manage stress and balance competing demands in a high throughput environment

Education

• Associates Degree required BS preferred in business, engineering, life sciences, or a related field

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink Biotechnologies, a Maravai LifeSciences company, is seeking a Process Development Associate I to join our growing team. This role for pDNA production, will assist with development and validation activities for GMP pDNA manufacturing. They will also assist with interdepartmental biomolecule R&D and CDMO projects as needed.

Responsibilities

• Assist with executing experiments with supervision in a laboratory setting
• Document, and summarize findings in batch records and/or lab notebooks
• Assists in projects between external customers and internal manufacturing teams, specifically for pDNA products
• Assists in the execution of scale-up processes of pDNA
• Participate in respectful scientific debates and discussions
• Maintain a safe, clean, and organized work environment
• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies.

Qualifications

• A Bachelor of Science in scientific field; preferably in Chemistry, Biochemistry, or Biology
• 1-2 years of relevant laboratory experience or equivalent; preferably in biotech or pharmaceutical development/manufacturing
• The ability to communicate clearly and precisely, both orally and in writing
• Ability to work on multiple tasks simultaneously and meet deadlines
• Experience working on cross functional teams and commitment to working in a fast-paced environment

Education

• A Bachelor of Science in scientific field; preferably in Chemistry, Biochemistry, or Biology

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink Biotechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Product Manager. The dynamic Product Manager will oversee all product management and forecasting of TriLink mRNA solutions, including CleanCap, mRNA and plasmid. This position will work to evaluate sales performances by products and formulate corporate long-range plans, goals, and objectives to exceed business goals. This position interacts with varying levels of internal and external customers with a team-focused approach. Strong business acumen and customer focus are essential.

Responsibilities

• Develops and maintains tools to effectively review and analyze currently marketed products, reporting actual vs. goals to senior management
• Develops and maintains forecasting, analysis and market share attainments for mRNA, CleanCap and plasmid product lines
• Develops, communicates, and coordinates new product/ service launch plans and strategy to the Commercial team to achieve or exceed share and net sales goals
• Coordinates with Supply Chain to ensure appropriate product inventory levels and expected Customer Service levels
• Stays current with industry trends and market intelligence, specifically with respect to the Company’s current product portfolio, to understand key competitive issues in relation to pricing and business strategy
• Provides proactive and in-depth financial analysis of product or market-specific business activity
• Conducts advanced analysis and business research to report on current and future product performance
• Gathers market and competitive intelligence and stays attuned to customer input
• Tracks and monitors monthly performance of product portfolio and recommends strategies to maximize opportunities
• Develops advertising, sales promotions, marketing materials, and other collateral as needed
• Develops innovative marketing programs for assigned commodity products
• Needs to be able to work in a fast-paced, multi-tasking environment
• Other assignments relative to current product portfolio management and analysis as needed
• Performs other duties as assigned

Qualifications

• BS degree in Biology, Molecular Biology, Biomedical Science or Genomics. MSc, MBA and/ or PhD is preferred
• 5-7 years of relevant work experience in the biopharmaceutical industry, with at least 2 years of experience in a CDMO setting
• Technical background in nucleic acid and cell therapy
• Experience with CRM and ERP, preferably SFDC and NetSuite
• Highly proficient in MS Office applications
• Strong communication skills
• Strong presentation skills
• Must demonstrate collaborative work style, with a strong ability to build relationships, gain credibility, and partner with internal customers
• Strong organizational and project management skills
• Strong strategic management skills
• Strong analytic skills with a familiarity with analytics programs and providing recommendations based upon data
• Ability to summarize detailed data into an actionable recommendation for a variety of audiences
• Ability to manage multiple projects simultaneously, with great attention to detail
• Ability to work in a fast paced, results, and deadline driven environment

Education

• BS degree in Biology, Molecular Biology, Biomedical Science or Genomics. MSc, MBA and/ or PhD is preferred

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink Biotechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Production Manager. The Production Manager will lead and develop a growing functional area manufacturing, specifically involving small bulk molecule and oligonucleotide production. The focus of the role will include resource scheduling, identifying opportunities for improvement within the team’s processes, and developing a road map to support capacity expansion. This role will serve as a primary point of contact with Quality, Supply Chain, and R&D teams while developing, improving, and sustaining production to help take us to the next level in our growth cycle.

Responsibilities

• Effectively and positively lead, train and advance team members to align with company goals and growth targets
• A comprehensive review of process workflows to identify and implement continuous improvement opportunities
• Analyze and manage work order releases with respect to capacity planning and material requirements
• Lead development of a high performing manufacturing culture focused on critical KPI’s such as On-Time Delivery (OTD), Schedule Adherence, and Quality/First Time and Safe Lab Practices
• Manages daily schedule with a focus on efficiency, meeting timelines, and maintaining a high quality of work
• Manages maintenance, turnover, and availability of inventory to meet production demands
• Ensures that manufacturing equipment is calibrated and maintained per SOP
• Hire and develops staff to retain talent and meet goals and KPI
• Perform other related duties as required or assigned

Qualifications

• Bachelor’s degree in life sciences, or a related field
• 2+ years of supervisory or management experience
• 3+ years of experience with oligo synthesis, small molecule synthesis, nucleic acid purification processes[AW3] [AW4]

Education

• Bachelor’s degree in life sciences, or a related field

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Production Supervisor. The Production Supervisor will lead a growing function area by owning capacity, productivity, continuous improvement efforts to meet long-term growth and profitability targets. The role will work closely with other Manufacturing areas, Quality, Planning, and R&D to develop, improve, and sustain production.

Responsibilities

• Plan a daily production schedule
• Review and approve manufacturing data and batch records
• Plan and manage capacity (Equipment and Labor) to meet quarterly demand
• Execute Change Orders, Deviations, CAPAs, and NCMRs
• Collaborate with development teams to lead improvement projects
• Develop tools and reports to trend and monitor manufacturing operations process health (Quality, rework, OTD) to provide and drive actionable information
• Hire and retain key talent to meet strategic and tactical goals and KPIs
• Maintains safe and clean work environment by following current good manufacturing practices (cGMP), 5S, and standards operating procedures areas

Qualifications

• BS degree in a scientific field, preferably in molecular biology
• 3+ years of related experience in the life science industry
• 2+ years supervisory experience leading teams
• Experience with 21CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
• Experience with enterprise systems such as NetSuite
• Strong multi-tasking abilities to complete activities in a fast-paced, deadline-driven environment
• Strong problem-solving skills and analytical skills applied to investigations
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to manage stress and balance competing demands in a high thorough put environment

Education

• BS degree in a scientific field, preferably in molecular biology

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Production Supervisor. Lead a growing manufacturing area by owning capacity, productivity, and continuous improvement efforts to meet long-term growth and profitability targets. The role will work closely with other Manufacturing areas, Quality, Planning, and R&D to develop, improve, and sustain production. This role is a second shift position, and will be working between the hours of 2 pm-midnight, Sunday - Thursday, or Tuesday - Saturday

Responsibilities

• Utilize ERP system and other assets to assist in production planning, inventory maintenance, and batch review/release
• Review and approve manufacturing data and batch records
• Plan and manage capacity (Equipment and Labor) to meet weekly and monthly production targets
• Execute Change Orders, Deviations, CAPAs, and NCMRs as needed
• Collaborate with development teams to lead improvement projects
• Report out on manufacturing operations process health (Quality, rework, OTD) to provide and drive actionable information
• Hire and retain key talent to meet strategic and tactical goals and KPIs
• Mentor and train group members, and lead project teams where necessary
• Maintains safe and clean work environment by following current good manufacturing practices (cGMP), 5S, and standards operating procedures

Qualifications

• BS degree in a scientific field or technical field
• At least five years of relevant manufacturing laboratory experience, including 2+ years supervisory experience leading production teams
• Experience with preparative scale chromatography on small molecules, peptides, or enzymes a plus
• Experience with 21CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
• Experience with enterprise systems such as NetSuite
• Strong multi-tasking abilities to complete activities in a fast-paced, deadline-driven environment
• Strong problem-solving skills and analytical skills applied to investigations
• Self-motivated and able to organize and prioritize multiple tasks

Education

• BS degree in a scientific field or technical field

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Quality Assurance Associate II. This position will support Quality Operations function, including the review and release batch records, review and approval of deviations, NCMRs, CAPAs, OOSs, and complaints. Ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.

Responsibilities

• Responsible for reviewing and approving batch records
• Responsible for initiating and reviewing Quality Events (e.g., Deviations, NCMRs, CAPA, Oss) to ensure appropriate investigations are completed in a timely manner
• Conduct quality investigations to access root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why’s, FMEA’s, Cause and Effect Diagrams, Process Mapping, etc.
• Review Change Control requests to ensure the appropriate documentation is in place for changes in materials, equipment, processes, and procedures
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations
• Work with various functions, including Manufacturing, QC, R&D, commercial customer service, technical support, facilities, IT, etc., to continuously improve the Quality Management System
• Perform other duties, as assigned

Qualifications

• Minimum, Bachelor's Degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.)
• Quality professional with a minimum of 2-5 years of relevant experience in the life science industry
• Must be able to work 11 AM to 8 PM). Will work on first shift (8 AM to 5 PM) for initial training. Support weekend as needed
• Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g., ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820),
• Strong and effective verbal and written communication skills
• Strong interpersonal, teamwork, and customer interfacing skills
• Strong problem-solving skills and analytical skills applied to investigations
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization

Education

• Minimum, Bachelor's Degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.)

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink Biotechnologies is seeking a QC Associate II. This position will be responsible for coordinating daily analytical testing, outsourced testing with contract labs, and routine data review of test results. This successful candidate will thrive in a flexible fast-paced environment and demonstrate excellent attention to detail.

Responsibilities

• Daily and weekly updating of QC group performance metrics.
• Routinely operate analytical UHPLC, mass spectrometer, and pH/conductivity meter.
• Monitor and daily planning of analytical UHPLC and mass spectometry tests from various departments using a Laboratory Information Management System (LIMS).
• Routine workup and delivery of test results.
• Coordinating outsourced tests with various contract labs for core manufacturing and GMP labs from sample submission to delivery of test results.
• Review instrument, performance qualification, and calibration logs for accuracy, completeness, and in accordance with GDP and internal requirements.
• Assists in the daily management of QC laboratory supplies and raw materials.

Qualifications

• B.S. or advanced degree in chemistry or biology or a related science required with 3-5 years of relevant experience.
• Computer skills (Database software, Microsoft Office Suite).
• Excellent communication skills (Email, Phone).
• Strong GMP and GLP background is highly desireable.

Education

• B.S. or advanced degree in chemistry or biology or a related science required with 3-5 years of relevant experience.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Quality Assurance Specialist to join their growing team. The dynamic Quality Assurance Specialist will support the operations function, including the review and release batch records, review and approval of deviations, NCMRs, CAPAs, OOSs, and complaints. Ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.

Responsibilities

• Responsible for reviewing and approving batch records.
• Responsible for reviewing and approving Quality Events (e.g., Deviations, NCMRs, CAPAs, OOSs, and complaints) to ensure appropriate investigations are completed timely.
• Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping, etc
• Support Raw Material release team in conducting raw material, component, in-process inspection and release in conformance to established product requirements, as needed.
• Lead cross-functional teams in risk identification and mitigation activities during risk management process
• Review and approve Change Control requests to ensure the appropriate documentation is in place for changes in materials, equipment, processes, procedures, etc
• Participate in the audit program, including conducting internal audits as needed
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations
• Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System
• Perform other duties, as assigned

Qualifications

• Minimum, Bachelor's Degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.)
• Quality professional with a minimum of 5 years of relevant experience in a life science industry
• Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g., ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820),
• Strong and effective verbal and written communication skills
• Strong interpersonal, teamwork, and customer interfacing skills
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization
• Able to work at least one day over the weekend

Education

• Minimum, Bachelor's Degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.)

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Quality Assurance Specialist, Operations to join their growing team. This role will support support activities related to customer communication and documentation management including Quality Agreements, customer notification requirements, audit response alignment with contracts, etc. In addition, this position will also support the review and approval of Quality Events (e.g. Complaints, Deviations, NCMRs, CAPAs, and OOSs).

Responsibilities

• Work with customers and suppliers to establish Quality Agreements that meet quality/regulatory requirements, internal capabilities, and customer needs.
• Manage customer notifications based on Quality Agreements, including change control and quality events (e.g. Deviations, NCMRs, CAPAs, and OOSs).
• Review customer audit responses to ensure alignment with Quality Agreements and quality/regulatory requirements.
• Work with commercial and product managers to ensure quality/regulatory requirements are aligned in Quality Agreements, Supply Agreements, custom product project orders, marketing materials, website, presentations, etc.
• Manage quality requirements for outsourced manufacturing activities.
• Review and approve Quality Events (e.g. Complaints, Deviations, NCMRs, CAPAs, and OOSs) to ensure appropriate investigations are completed timely. Notify customer where applicable.
• Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping, etc.
• Support external quality audits (e.g. customers, ISO, etc.).
• Maintain and report on quality metrics related to customer activities.
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
• Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
• Perform other duties, as assigned.

Qualifications

• Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
• Quality professional with a minimum of 5 years relevant experience in a life science industry.
• Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g. ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820),
• Strong and effective verbal and written communication skills.
• Strong interpersonal, teamwork and customer interfacing skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.

Education

• Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink Biotechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Quality Assurance Specialist to join our growing team and the Quality Operations function, including the review and release batch records,review and approval of deviations, NCMRs, CAPAs, OOSs and complaints. Ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.

This position will work on second shift (3PM to 12AM) and weekend (Saturday to Wednesday).

Responsibilities

• Responsible for reviewing and approving batch records.
• Responsible for initiating and reviewing Quality Events (e.g. Deviations, NCMRs, CAPA and OOSs) to ensure appropriate investigations are completed in a timely manner.
• Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping, etc.
• Review Change Control requests to ensure the appropriate documentation is in place for changes in materials, equipment, processes, procedures, etc.
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
• Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
• Perform other duties, as assigned

Qualifications

• Minimum, Bachelor's Degree in scientific discipline (e.g. Chemistry, Biology, Bioengineering, etc.).
• Quality professional with a minimum of 5 years relevant experience in a life science industry.
• Must work 11 AM-8PM.
• Will work on first shift (8AM to 5PM Monday to Friday) for initial training.
• Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g. ICH Q7 Practice
• Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820),
• DocuSign Envelope ID: A16D8404-E0CD-4E06-BBE8-DB3C5B7C1338
• Strong and effective verbal and written communication skills.
• Strong interpersonal, teamwork and customer interfacing skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the
• organization.

Education

• Minimum, Bachelor's Degree in scientific discipline (e.g. Chemistry, Biology, Bioengineering, etc.).

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink Biotechnologies, a Maravai LifeSciences company, is seeking a Senior Laboratory Technician to join our growing team. This role will contribute to the department’s success by maintaining all equipment, production and storage areas, supplies, and raw materials. This position will follow SOPs and batch records to produce reagents, buffers, and products to GMP standards.

Responsibilities

• Maintenance of GMP areas for cleanliness and organization
• Maintenance of equipment, including set-up, cleaning, operation, preventative maintenance, coordinating calibration, verifying appropriate status labeling, and keeping equipment list up to date
• Verification and maintenance of supplies and raw materials, including submitting reorder points, submitting purchase orders/picks, replenishment, and keeping accurate inventory counts
• Assisting Manufacturing Associates and leads with daily production needs, which includes cleaning and bringing materials into the controlled environment
• Documenting quality events per our QMS and GDP requirements

Qualifications

• High School degree required. Studies in a scientific field preferred or equivalent work experience in a GMP environment preferred.
• Experience working in a controlled ISO class cleanroom environment preferred
• Experience with NetSuite or equivalent ERP system preferred
• Experience with a document control system preferred
• Strong communication skills, including ability to follow written and verbal instructions
• Self-motivated and able to organize and prioritize multiple tasks
• Works well as part of a team
• Proficiency in Microsoft Office Suite

Education

• BS degree in life sciences, or a related field, or 4+ years of relevant work experience with a GED or equivalent 3-5 years of experience in buffer formulation or manufacturing

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink Biotechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Senior Manufacturing Associate. Produces research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; performing HPLC purification; documenting actions; Performing projects for process improvement and scale-up.

Responsibilities

• Prepares for production by reviewing the production schedule; reviewing specifications; calculating requirements; assembling materials and supplies
• Performs dilutions and spectrophotometric readings to quantify compounds.
• Operates and maintains a rotary evaporator to concentrate compounds.
• Operates and maintains HPLC/UPLC equipment for purification and analytical QC
• Performs wet chemistry reactions, primarily phosphorylation chemistry
• Maintains a safe and clean work environment
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices
• Performs projects based on process improvements and scale-up
• Performs characterization assays centered around developmental improvements
• Onboards and authors procedures for new equipment
• Transfers developmental improvements to manufacturing team through training/technical transfer

Qualifications

• Minimum a Bachelor’s of Science in chemistry-related field.
• Preferred M.S. in a Chemistry related field
• At least 5 years of relevant manufacturing laboratory experience, HPLC purification, NTP synthesis, and scale-up
• Experience with Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Experience in compiling, analyzing, and presenting technical data

Education

• Minimum a Bachelor’s of Science in chemistry-related field.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Senior Manufacturing Associate.  The associate will produce research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment, performing wet chemistry reactions, utilizing pilot grade purification systems, authoring and implementing SOPs, and documenting actions in batch records.  

Responsibilities

• Prepares for production by reviewing production schedule; studying and clarifying specifications calculating requirements; assembling materials and supplies.
• Maintains a safe and clean work environment by following standard operating procedures.
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices.
• Trains and mentors new team members.
• Onboards and authors procedures for new equipment
• Identifies key process bottlenecks and implements process improvements to minimize bottleneck.
• Updates job knowledge by participating in training opportunities.
• Performs characterization assays centered around developmental improvements
• Transfers developmental improvements to manufacturing team through training/technical transfer

Qualifications

• M.S. in a relevant scientific field, preferably Chemistry/Biochemistry with 5+ years of industry experience.
• Ph.D. in a relevant scientific field, preferably Chemistry/Biochemistry with 2+ years of industry experience.
• Hands-on laboratory experience with an emphasis on HPLC purification and/or small molecule synthesis
• Experience with drafting, editing, implementing, and executing Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to mentor other team members on processes they have become proficient at executing.

Education

• M.S. in a relevant scientific field, preferably Chemistry/Biochemistry with 5+ years of industry experience.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is a Maravai LifeSciences company looking for a Senior Manufacturing Engineer. As a Manufacturing Engineer, you will provide technical leadership in sustaining efforts in a high-volume manufacturing environment. You will troubleshoot issues, define, and perform preventative maintenance on mechanical, electrical, and fluidics systems. You will work to improve equipment uptime and reliability. You will also apply organic chemistry principles in troubleshooting manufacturing and equipment process issues.

Responsibilities

• Provide maintenance, troubleshooting, and process support to a high-volume manufacturing organization
• Define and perform preventative maintenance on mechanical, electrical, and fluidics systems
• Use mechanical, optical, fluidics, and organic chemistry knowledge to troubleshoot manufacturing process and equipment issues as they arise
• Perform basic computer/software troubleshooting
• Develop, write and update manuals and procedures
• Train other engineers and production personnel on the procedure, process, and equipment changes
• Work in a team environment to improve equipment reliability and uptime
• Operate within the Quality Management System to maintain an audit-ready state
• Coordinate vendor support with the manufacturing areas
• Construct and execute controlled experiments (including DOE's) to address equipment-related yield and quality issues and drives implementation of solutions in a production environment to meet production goals
• 10-20% travel required

Qualifications

• B.S. in Electrical, Mechanical Engineering, Physics or an associate degree in the related field
• Minimum of 5 years' experience in a high volume manufacturing environment preferred
• Strong demonstrated mechanical aptitude, and problem-solving abilities are required.
• Experience in writing procedures and training is required
• Basic computer troubleshooting skills are required
• Good interdepartmental communication skills and documentation skills are required
• Demonstrated ability to work independently is required
• Candidate preferably has experience with mechanical/electrical systems, fluidics, and organic chemistry processes at pilot plant scale
• Experience working in quality systems - ISO 9001 and 21CFR - a plus
• Experience with Statistical Process Control and DOE techniques is a plus

Education

• B.S. in Electrical, Mechanical Engineering, Physics or an associate degree in the related field

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is seeking a Senior Production Manager, Plasmid. This individual will lead and develop our Plasmid DNA Production group. Focus of this newly created role will include owning resource and process scheduling, monitoring manufacturing health, identifying opportunities for improvement, and developing a road map for increasing capacity and scale-up opportunities. S/he will interact with Development, Quality Control, and Quality Assurance to assure robust, efficient, and compliant processes are implemented and maintained. S/he will support adherence to relevant regulatory requirements and company Standard Operating Procedures as appropriate.

Responsibilities

• Provide leadership for upstream and downstream plasmid DNA (research and GMP-grade) production activities, including active contribution to development and technology transfer activities
• Supervise manufacturing personnel in production of plasmid DNA conforming to cGMP guidelines.
• Oversee installation, commission, and troubleshooting equipment as needed
• Comprehensive review of process workflows to identify and implement continuous improvement opportunities
• Collaborate with supply chain, quality, and manufacturing sciences and technology to evaluate manufacturing proposals, technologies, and processes.
• Analyze orders, market forecasts, and trend analysis to ensure the resources, capacity, and the flow path can meet demands
• Analyze work order releases with respect to capacity planning and material requirements.
• Organize and facilitate weekly scheduling meetings to drive improved performance in schedule readiness and schedule adherence metrics for the site
• Participate in the development of a high performing culture focused on critical KPI’s such as: On-Time Delivery (OTD), Schedule adherence, and Quality/First Time Pass
• Develop processes and tools to trend efficiencies and opportunities to provide and drive actionable information, including scorecards and visual dashboards
• Strong commitment to continuous improvement
• Hire and retain key talent to meet strategic and tactical goals and KPI’s
• Perform other related duties as required or assigned

Qualifications

• Bachelor’s degree in life sciences or engineering with a minimum of 10 years of relevant experience and minimum of 5 years of supervisory experience
• Experience with a minimum of 5 years of cGMP manufacturing experience and demonstrated, applied knowledge of CMC and regulatory requirements
• Experience with plasmid DNA manufacturing processes is required.
• Significant experience in manufacturing operations, including budgeting, CapEx procurement and I/O/Q, safety, and status reporting to Senior Management is preferred
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports
• Ability to draft SOPs and support root cause investigations (i.e., deviations, NCMRs, CAPA)
• Experience with ERP/MRP systems required; NetSuite expertise strongly preferred
• Proficient with Microsoft Office
• Experience scheduling both non-recurring and recurring production needs
• Experience with 21 CFR 820, ICH Q7, and/or ISO 9001 requirements a plus
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

Education

• Bachelor’s degree in life sciences or engineering with a minimum of 10 years of relevant experience and minimum of 5 years of supervisory experience

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Senior Quality Control Associate. This person will be responsible for coordinating daily analytical testing, outsource testing with contracted labs, and routine of test results. The successful candidate will thrive in a flexible fast-paced environment and demonstrate excellent judgment.

Responsibilities

• Routinely operate QC instrumentation to support all QC testing requirements (including but not limited to UHPLC, mass spectrometer, qPCR, fragment analyzer, Bioanalyzer)
• Participate in test method validation/qualification/verification, including lab work, writing and review of protocols and reports, and client communications as required
• Provide phase-appropriate cGMP analytical support to Manufacturing, including but not limited to testing and documentation preparation
• Monitor daily planning of analytical testing from various departments using a Laboratory Information Management System (LIMS) to assist QC Supervisor and Manager with timely delivery of testing
• Provide analytical support to AD and PD groups as required
• Workup, review, and delivery of test results
• Periodically review and update QC SOPs

Qualifications

• B.S. or advanced degree in chemistry or biology or related science required with 5-6 years of relevant experience; familiarity with mass spectrometric techniques is preferred.
• Computer skills (Database software, Microsoft Office Suite)
• Excellent communication skills (Email, Phone)
• Excellent problem-solving and troubleshooting skills
• Strong technical writing skills
• Experience with molecular biology methods in addition to traditional analytical chemistry techniques is highly desirable
• Strong GMP and GLP background and working knowledge of USP and Ph. Eur. is highly desirable

Education

• B.S. or advanced degree in chemistry or biology or related science required with 5-6 years of relevant experience; familiarity with mass spectrometric techniques is preferred.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies is looking for a Senior Quality Validation Engineer. The Senior Validation Engineer will lead to process validation, cleaning validation, and equipment validation for the manufacturing facilities to meet current GMP and industry standards.

Responsibilities

• Responsible for performing manufacturing processes validation, cleaning validation, and equipment validation. This includes developing validation master plans preparing protocols, analyzing test results, and preparing technical reports
• Coordinates validation activities with, and seeks team support from, Project Management, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget
• Review and approve proposed changes for products by performing risk assessments, providing guidance and support, and assessing the adequacy of verifications and validations
• Maintains up-to-date knowledge of validation requirements, practices, and procedures across the industry
• Mentor and coach engineering, manufacturing, and quality personnel on the best practices for validations
• Demonstrates excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy, and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility, and education levels
• Complies with Health, Safety and Environmental responsibilities applicable to the position
• Manage validation records in an electronic database system
• Support client audits as needed
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations
• Perform other duties as assigned

Qualifications

• BS Degree or equivalent in a scientific discipline.
• Quality professional with a minimum of 8 years of relevant experience in a life science industry, including 5 years in process and cleaning validation
• Requires knowledge of FDA regulated biotechnology or drug validation requirements (e.g., 21 CFR 210, 211 or 21 CFR 820 or ICH Q7)
• Experience executing validation projects for biotech or pharmaceutical production projects
• Must have specific knowledge of validation methodologies and principles
• Strong technical writing and analytical skills
• Expertise in risk management and application of FMEAs to validations
• Understand mRNA, pDNA manufacturing process a plus

Education

• BS Degree or equivalent in a scientific discipline.

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now