Careers

Job Description

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

TriLink BioTechnologies is seeking a Director, Manufacturing Sciences, Technologies, and Engineering to join our growing team. As part of the Senior Leadership team at TriLink, this individual will oversee Engineering, Technical Operations, and Maintenance. Specifically this leader will ensure calibration and validation of operations, manage budgets, direct routine maintenance, manage risk and manage contractors. This role will work closely with Manufacturing, Quality, R&D, Facilities engineering, and IT on strategic projects including M&A, TriLink capital management, computer systems and process controls, assist with growth and layout strategy, along with strategic facilities requirements and process development.

Responsibilities

• Provide stable and effective leadership, support, and direction to the facility, creating an organization dedicated to innovation, effectiveness, safety, and flexibility
• Participate and lead, when required, key strategic initiatives including 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
• Coordinate and facilitate key process and equipment upgrades in support of improving existing processes and development and implementation of new strategic processes and equipment at TriLink
• 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, or Science. MS or PHD Preferred
• 10+ years of increasingly responsible maintenance and operations experience at the supervisory or management level
• Experience as a cross-functional leader with demonstrated results in life sciences/chemistry manufacturing operations
• Knowledge of equipment and process design with an emphasis on managing maintenance and technical operational teams.
• 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 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

Education

• Required BS Engineering, or Science. MS or PHD 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 Director of Product Marketing for our global portfolio of products and CDMO services. The dynamic Director of Product Marketing will oversee the development and execution of the global go to market strategy and will interact with varying levels of internal and external stakeholders with a team-focused approach for continuous improvement. The Director of Product Marketing will have responsibility for driving core & strategic revenue growth, product/service awareness & adoption, customer engagement, lead generation, marketing budget oversight, support of digital marketing channels and building brand equity.

Responsibilities

• Develop and execute go to market strategy to support short and long-term business objectives including revenue growth in key channels, product/service lines and customer segments.
• Develop messaging and tools that communicate the value/brand directly to customers through best practice utilization of traditional and digital marketing channels.
• Work with internal marcom and liaise with external media agencies to develop campaign requirements, content and creative.
• Provide support to distributors & business development team for implementation of programs to drive lead generation and awareness activities to meet revenue goals.
• Improve the effectiveness of marketing programs through better targeting and better user experience design across digital channels including website.
• Develop, implement and maintain lead tracking, campaign ROI, marketing metrics and other sales/marketing analytics using Salesforce, Pardot, Google DataStudio and other tools.
• Effectively utilize marketing automation, CRM and social media tools for digital engagement.
• Leverage KOL relationships for customer engagement marketing, events and customer testimonials.
• Manage trade show schedule, planning and attendance including organizing and delivering training workshops and seminars.
• Develop and execute plans for the launch of new products/services.

Qualifications

• BS in Life Science field required. Advanced degree (PhD, MBA) preferred.
• 5+ years experience leading product marketing teams in the life science / biotech industry with knowledge of DNA / RNA products and services.
• Experience working in a CMDO/GMP environment a plus.
• Proven track record of demonstrated capability in a broad range of areas including, but not limited to, marketing, leadership and product/service launch programs.
• Experience with web, social media, Salesforce and marketing automation tools for digital marketing.
• Excellent organizational, analytical, strategic, and interpersonal skills.
• Strong leadership capabilities, particularly in influencing and motivating teams to achieve group goals.
• Must be able to travel as required by the needs of the role (25-30%).

Education

• BS in Life Science field required. Advanced degree (PhD, MBA) 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 Engineer to join our growing team. Responsibilities include operations and maintenance of a variety of trades including structural, mechanical, electrical and plumbing systems. In addition. This position will perform diverse manual tasks and assist with maintenance with support from contracted services.

Responsibilities

• Perform periodic inspections of HVAC systems and their components to evaluate condition, identify necessary repairs and recommend preventive maintenance.
• Diagnose causes of HVAC systems problems and identify solutions.
• Maintain, operate, and troubleshoot air handlers, VAV boxes, and all associated air exchangers, pumps, controls and monitoring, etc.
• Maintain and operate a computerized maintenance program.
• Ensure all building equipment and systems are operated in a safe manner and are in compliance with all applicable codes and regulations.
• Support in small projects and minor repairs, such as patching and painting, tiling, flooring, door hardware, minor plumbing and electrical repairs, carpentry and furniture moves.
• Respond to minor janitorial requirements as well as maintaining of the work areas and technical rooms.
• Responsibility for equipment startup, monitoring, and efficient operation.
• Respond to facilities complaints and assist other trades as necessary.
• Read and interpret drawings and control schematics.
• Assist other trades as assigned.
• Complete all other tasks required by his immediate supervisor.

Qualifications

• 2 year Degree, technical school degree or equivalent experience
• HVAC Repair Training, preferred
• General electrical wiring/installation training, preferred
• Minimum 5 years experience as a Building or Facilities Engineer, or with an equivalent trade in the Biotech industry.
• Experience working in a GMP environment and completion of GMP documentation
• OSHA safe work practices
• Experience writing standard operating procedures
• Building Management System Experience (Rees, Envision) a plus
• Experience with CMMS, preferred
• Good troubleshooting skills – mechanical / electrical / plumbing
• Comply with Good Documentation Practices
• Must be able to coordinate multiple contract services simultaneously
• Good communication and organizational skills
• Proficient in all Microsoft Office applications
• Must be able to lift 50 pounds

Education

• 2 year Degree, technical school degree or equivalent experience
• HVAC Repair Training 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 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 Group Lead, Shared Services to join their growing team. The Group Lead will provide on-the-job leadership for our shared services production team with direct oversite of technicians who will be responsible for buffer formulations, final product release, kitting, and fill/finish. This role will ensure the technicians are following proper procedures during the production process, monitor inventory levels and controls to ensure accurate transactions are entered, and coordinate with production managers to meet quality and scheduling objectives. They will also assist in training, drafting deviations, generating work orders and other ERP transactions, and drafting technical documents for manufacturing processes. This position will report into a Production Manager.

Responsibilities

• Schedules daily activities for shared services manufacturing team.
• Maintains safe and clean work environment.
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
• Primary point of contact for multiple intracompany manufacturing groups.
• Documents work by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices.
• Maintain accurate inventory levels by reviewing ERP transactions and monitoring scheduled cycle counts
• Primary in ERP work order creation, review, completions, and closures.
• Performs and tracks projects based on process improvements and scale up.
• Reviews batch records and standard operating procedures.
• Onboards and authors procedures for new equipment and processes.
• Supervises work of technicians and provides updates to the production manager.
• Oversees training of new processes and onboarding for manufacturing staff.

Qualifications

• BS degree in chemistry or biological science preferred.
• 1+ years management experience in a life science manufacturing environment.
• 2+ years experience in a life science manufacturing environment.
• Excellent written and verbal communication skills.
• Solid organizational skills with the ability to organize and track several projects simultaneously.
• Ability to communicate effectively.
• Proficiency in Microsoft Office Suite.
• Experience with data entry and transactions within an ERP system.
• Excellent organizational, analytical, strategic and interpersonal skills
• Strong Indirect leadership capabilities, particularly in influencing and motivating teams to achieve group goals.

Education

• BS degree in chemistry or biological science 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 looking for an Inventory Analyst. The Inventory Analyst Supports TriLink Operations and will be part of the Supply Chain organization. The Inventory Analyst / Cycle Count Coordinator works to resolve and prevent inventory discrepancies and coordinates the cycle count program. The Inventory Analyst/Cycle Counter receives specific work assignments from the Materials Supervisor.

Responsibilities

• Maintain inventory accuracy through execution of our cycle count program, including training and monitoring cycle counters
• Analyze inventory policies and identify any deficiencies and inefficiencies, make correctional recommendations, and oversee their implementation
• Investigate and resolve inventory discrepancies, including root cause analysis
• Enter inventory transactions in the ERP system as required
• File necessary documents as directed by Materials Supervisor
• Work on continuous improvement and other projects as directed by the Materials Supervisor.
• Maintain warehouse layout and stocking locations: Racks/labeling/ERP location maintenance
• Identify and resolve BOM/Routing issues
• Maintain and publish weekly and monthly KPI metrics
• Act as backup/additional resource for the materials team as needed
• Works in a safe manner at all times, ensure that safety rules are followed without exception, and participates fully in any and all Company safety programs
• Ensures that all work is performed in accordance with and adheres to ISO and Quality standards.
• Reasonable accommodations may be made for individuals with disabilities to perform essential duties. Physical Demands: • lifting
• Maximum moving requirement (pounds): 150 (with assistance)
• Maintaining physical condition necessary for the following: Frequent standing, walking, sitting, kneeling, crouching, stooping, squatting, twisting upper body, or climbing
• Working at heights off the ground up to 8 feet
• Vision requirements: Close, distance, and peripheral vision; depth perception. Work Environment
• Work location(s): Office; metal fabrication/assembly shop. Exposure to Fumes, airborne particles, wet/humid (non-weather) conditions, toxic/caustic chemicals, moving mechanical parts/equipment, inclement weather conditions
• Personal protective equipment requirement: Safety glasses and steel toe shoes when in shop areas

Qualifications

• Educational: High School Graduate, related technical training (high school or beyond) is desirable but not essential
• Computer/ERP Skills: Intermediate working knowledge of Excel and mid-level understanding of ERP – Syteline would be a plus
• Working knowledge of current GMP Regulations required Experience with ERP systems required, preferably NetSuite
• Certificates, Licenses, etc.: CPIM or CSCP certification would be a plus
• Ability to plan, organize, and direct multiple work activities simultaneously
• Ability to solve complex problems individually and quickly
• Ability to create solutions to previously unsolved issues
• Ability to communicate (oral/written) with employees and others effectively
• Ability to lead subordinates safely and efficiently
• Ability to build and maintain positive employee relationships (in-person/phone/e-mail).
• Ability to read, understand, and interpret material specifications, purchasing and production documents, shop drawings, and blueprints.
• Knowledge of occupational hazards and the ability to follow safe work practices
• Experiential: 2-5 years inventory control, material handling or manufacturing experience preferred

Education

• Educational: High School Graduate, related technical training (high school or beyond) is desirable but not essential

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 responsible for producing 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.

Shifts Available:

· Monday - Friday, 6:00am - 3:00pm

· Tuesday - Saturday, 2:30pm - 11:30pm

· Saturday - Thursday, 6:00am - 3:00pm

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’s 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 bulk reagent formulation, HPLC purification of small molecules, 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 executin

Education

• A Bachelor’s 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.

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.
• Rains 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 2 years of experience working in a professional lab.
• 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 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 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, 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 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 Process Development Associate II for support of mRNA synthesis manufacturing process improvements to optimize yields and reduce side product formation. Support interdepartmental biomolecule R&D and CDMO projects.

Responsibilities

• Responsible for executing cGMP projects between external customers and internal manufacturing teams, specifically for mRNA active pharmaceutical ingredients
• Support the development of scale up production process of mRNA for clinical manufacture
• Required to work in the laboratory with minimal supervision
• Responsible for executing experimental protocols and preparing internal reports summarizing results
• Provide suggestions in scientific debates and discussions
• Maintain safe, clean, and organized work environment
• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies.

Qualifications

• Bachelor of Science in scientific field; preferably in Chemistry, Biochemistry, or Biology
• At least 3-5 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 communicate problems/observations and effectively offer suggestions
• Ability to work on multiple tasks simultaneously and meet project deadlines
• Experience working on cross-functional teams and a commitment to working in a fast-paced environment
• In addition to the above requirements, tech transfer to manufacturing, prior scale-up manufacturing experience, and process optimization experience are desirable

Education

• 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 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 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 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 Production Manager, mRNA. This individual will lead our mRNA Production group. Focus of this 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 production activities, including active contribution to development and technology transfer activities
• 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
• Maintain a safe and clean work environment by following current good manufacturing practices (cGMP), 5S and standard operating procedures
• 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 8 years of relevant experience and a minimum of 3 years of supervisory experience. Molecular biology experience is a plus
• Experience with cGMP manufacturing is preferred
• 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 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 8 years of relevant experience and a minimum of 3 years of supervisory experience. Molecular biology experience 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 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 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 Quality Assurance Specialist to support Quality Operations function, including the review and release batch records, review and approval of deviations, NCMRs, CAPAs, OOSs and complaints. This role will 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 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 (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 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 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 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 Senior Business Development Manager to join our team in leading our efforts on the East Coast. This dynamic role is responsible for driving core and custom product revenue via direct client interactions to support the company’s growth objectives, develop and nurture key/strategic account relationships, foster collaborations with KOLs, and work with GMP team to introduce new clients into the GMP pipeline. Successful performance increases core and custom revenue, profitability, and market share while developing long term, beneficial partnerships for TriLink Biotechnologies.

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
• Develop high level, strategic relationships to develop new OEM, diagnostic, life science and therapeutic strategic accounts
• Develop deep knowledge of territory and clients leading to the recurring accurate assessment of opportunities and precise forecasting of sales
• Maintain critical current knowledge of mRNA, oligo and bioconjugation applications and trends via attendance at key conferences, meetings, and symposia
• Actively contribute Voice of Customer (VOC) to the development of marketing strategies and tactics to support core and custom products sales objectives
• Contribute to effective educational and marketing campaigns to support the expansion of both brand and product awareness in the custom oligo, mRNA, bioconjugation, amidite and reagent sectors
• 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. An advanced degree is a plus
• Minimum 5 years of commercial experience in Molecular Biology, Genomics and/or Biologic CMO sales and/or business development
• 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 in 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 40% of the time to support sales, business development activities, conferences, and training
• Location: Boston, Washington, D.C. 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. An 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 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 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 Senior Manufacturing Engineer to be part of a new and growing engineering team at TriLink providing process engineering development and support for automating, scaling-up, system integrating, and sustaining our manufacturing processes. We are looking for a Senior Manufacturing Engineering candidate to support the implementation of our manufacturing operations into a Manufacturing Execution System (MES) and our quality control operations into a Laboratory Informatics Management System (LIMS). This role will work closely with Manufacturing, Quality, R&D, and IT to develop, improve, and sustain operations to help us take the next steps forward in our growth cycle.

Responsibilities

Job duties include but are not limited to:

• Lead the efforts to digitize the manufacturing and quality control process through development, implementation, lifecycle management and support of MES/LIMS systems.
• Develop electronic batch records (eBRs) for manufacturing within MES: gather system/end user requirements; complete design, implementation, and testing/validation.
• Support system go live activities, master data creation and maintenance.
• Provide technical guidance in respect to MES/LIMS capabilities and system GMP Compliance.
• Assist business owners to develop system standards and ways of working.
• Develop and maintain written procedures and training content as required.
• Participate in all activities required to support production, including but not limited to; MES/LIMS user support, troubleshooting, investigations, periodic reviews, root cause analysis, safety and Quality preventative and corrective actions.
• Support site audits and inspections and implement corrections as needed.

Qualifications

• B.S. Degree or higher in Chemistry, Biochemistry, Bioengineering, Chemical Engineering or other related field with 3-5+ years of industry experience
• Previous experience working with a MES or LIMS required
• Work experience in the biotech, pharmaceutical or chemical industries is desirable
• Experience with chemical processes (preferably organic) preferred
• Programming language experience a plus (R, C++, C#, Javascript)
• High level problem solving and reasoning skills required
• High level computer skills are required
• Experience drafting user, system, and software requirements is preferred
• Experience with statistics, Statistical Process Control, and DOE techniques is a plus
• Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
• Lean/Six Sigma experience a plus
• This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.
• Strong multitasking 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 composure

Education

• B.S. Degree or higher in Chemistry, Biochemistry, Bioengineering, Chemical Engineering or other related field with 3-5+ years of industry experience

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 Senior Product Manager. The dynamic Sr Product Manager will oversee all product management and forecasting of TriLink GMP contract development and service business. This position will work to evaluate sales performances by services/ products and formulate corporate long-range plans, goals, and objectives to exceed business goals. This position will interact with varying levels of internal and external customers with a team-focused approach for continuous improvements. Strong business acumen, customer focus, and experience in CDMO are essential.

Responsibilities

• Develops and maintains tools to effectively review, analyze and expand TriLink GMP business, reporting actual vs. goals to senior management
• Develops and maintains forecasting, analysis, and market share attainments for TriLink CDMO services, including GMP manufacturing of mRNA, CleanCap, plasmid, and oligonucleotides
• 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 process, pricing, and business strategy in mRNA/ oligo therapeutic and diagnostic market
• Coordinates with cross-functional stakeholders, including Program Management and Sales to execute best-in-class customer journey and expected customer excellence
• Gathers market and competitive intelligence and stays attuned to customer input
• Monitors and aligns GMP client requirements with TriLink capabilities to effectively coordinate and execute on-time program delivery
• Develops, communicates, and coordinates improvements of GMP process and strategy, and providing sales training to the Commercial team to achieve or exceed share and net sales goals
• Provides proactive and in-depth financial analysis of a product or market-specific business activity
• Conducts advanced analysis and business research to report on current and future product performance
• Tracks and monitors monthly performance of product portfolio and recommends strategies to maximize opportunities

Qualifications

• BS degree in Biology, Molecular Biology, Biomedical Science or Genomics. MSc, MBA, and/ or Ph.D. is preferred
• At least 5 years of relevant work experience in the biopharmaceutical industry, with at least 3 years of product management experience, preferably in a CDMO setting
• Technical background in nucleic acid, gene editing, cell therapy, and/ or bioprocessing
• Experience with CRM and ERP, preferably SFDC and NetSuite
• Highly proficient in MS Office applications
• Strong communication skills
• Strong presentation skills
• Must demonstrate a 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 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 Ph.D. is 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 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 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 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 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 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 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 Technical Inside Sales Specialist. The Technical Inside Sales Specialist (TISS) role will interact with clients and employees at all levels. It will have responsibility for driving sales, presales technical support questions, custom quotations, and coordination with operations. The TISS will provide the highest quality of client communication in the form of accurate quotations, order fulfillment, and consultative technical advice. The TISS will be a critical part of the TriLink BioTechnologies commercial team and work closely and collaboratively with Business Development Managers to drive and develop new opportunities to meet and exceed revenue goals.

Responsibilities

• Provide a high level of client communication and presales technical support to drive sales
• Respond to and own all inbound requests by email and phone, fulfilling requests in a friendly, professional, and timely manner. Log and track client interactions through CRM (Salesforce)
• Develop and deliver specific and accurate custom quotations to clients focused on rapidly moving from quotation to order
• Work closely with Business Development Managers to exceed monthly, quarterly, and annual TriLink BioTechnologies revenue goals
• Work closely with Business Development Managers to develop accurate monthly and quarterly sales forecasts
• Provide clear, professional communications with internal teams to ensure efficient execution of order fulfillment. Interact with Quality and technical teams to support product knowledge and client issues
• Take ownership of client issues while utilizing the appropriate TriLink resources
• Interact with Marketing and Sales to ensure lead/opportunity follow up via CRM
• Provide critical client feedback (Voice of Client) to Marketing and Product Development Teams

Qualifications

• BS or higher in life science with 5+ years life science industry experience in Commercial (sales)
• Bias for action/demonstrated a level of urgency
• Preferable: Direct client experience
• Professional communication proficiency
• Attention to detail
• Technical capacity
• Problem-solving/analytical thinking
• Strong multitasking abilities to complete activities in a fast paced, deadline driven environment
• Results driven self- starter
• Ability to manage stress and maintain composer

Education

• BS or higher in life science with 5+ years life science industry experience in Commercial (sales)

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