Careers

Job Description

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

TriLink BioTechnologies is seeking an Alliance Manager to join our growing team. This role will act as a conductor who crafts a compelling business plan, obtains executive buy-in up and down the chain of command, and works with business units and salespeople to execute. This position requires deep knowledge of the business, political savvy, sophisticated negotiation skills, and an ability to get beyond what is being said and understand the meaning and implications behind the words. It often requires great amounts of both tenacity and empathy. The role requires difficult and frank discussions with people senior to the Alliance Manager and entails challenging traditional hierarchies, lines of authority, and existing ways of working within each partner organization. A large focus is finding ways to create new value within company partnerships with key long-term accounts.

Responsibilities

• Manage and grow existing strategic alliance partner relationships including ongoing communications, periodic reviews, and facilitating periodic interactions (QBR's)
• Manage partner forecast reporting and growth initiatives
• Understand the company and partner supply chain and other critical factors to ensure timely delivery of products that support client production demands.
• Understand company manufacturing workflows, qualify systems and inventory/supply chain management systems
• Proactively pursue relationships with new potential partners, develop go-to-market business plans (evaluating the financial and non-financial benefits and risks of new partnerships)
• Negotiate and execute partner contracts and agreements
• Perform ongoing management and assessment of each partnership, adjusting terms and modifying relationships, as necessary
• Collaborate with internal and external marketing departments to develop joint collateral as needed
• Collaborate with internal stakeholders to address failures in partner delivery that require attention and action
• Professionally and proactively communicate with external and internal customers
• Work with internal team to create a customer-facing document of the highest professional level and accuracy
• Attend key conferences, meetings
• Other duties as assigned

Qualifications

• Degree in Molecular Biology, Biochemistry or allied degree, MBA degree is a plus. Minimum 3+ years in relevant areas with commercial experience in Molecular Biology, Genomics and/or Biologic CMO sales and/or business development.
• Experience selling/negotiating to large multinational organizations
• Proven track record of demonstrated capability in a broad range of areas including but not limited to business development, marketing, and sales
• Excellent computer software skills with demonstrated expertise in Excel, Word, PowerPoint, and SFDC.
• Excellent knowledge of workflows within CRM systems (SFDC preferred), implementation of these tools, and building meaningful reports to assist the organization in understanding business pipeline requirements.
• Proficiency in verbal and written communication in English
• 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
• Strong Indirect leadership capabilities, particularly in influencing and motivating teams to achieve group goals.

Education

• Degree in Molecular Biology, Biochemistry or allied degree, MBA degree is a plus. Minimum 3+ years in relevant areas with commercial experience in Molecular Biology, Genomics and/or Biologic CMO sales and/or business development

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 Computer System Validation (CSV) Engineer responsible for managing the CSV program, including computer systems, equipment with computers or PLC controllers, and data integrity generated by the computer programs. Ensure compliance with applicable domestic and international standards and regulations.

Responsibilities

• Develop validation plans, protocols, and reports for validation activities
• Execute validation protocols and interact with other functions to facilitate protocol execution as necessary
• Perform gap assessments of current computer systems to industry standards and develop plans to close gaps
• Work with global and local IT functions for validation of global computer systems that go across sites (e.g., MasterControl, NetSuite, etc.)
• Provide input in the global data integrity program for computer systems and lead various projects for implementation and maintenance of the program
• Coordinate validation activities across various departments and provide updates to management to ensure projects stay on track
• Oversee validation activities from contractors and vendors as necessary
• Develop processes and procedures for computer system validation and change control, including equipment with computers or PLC controllers
• Apply expertise in current computer validation requirements by industry standards and FDA to develop and implement compliant computer validation strategies.
• Demonstrate 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
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations
• Perform other duties as assigned

Qualifications

• Bachelor's Degree in Engineering or Computer Science 
• A minimum of 5 years' experience in related field of work within the biotech or pharmaceutical industry. 
• Experience developing plans, protocols, and executing computer validation projects in the biotech or pharmaceutical industries.
• Good understanding of computer system validation and computer system management in cGMP operations. Must have specific knowledge of computer validation methodologies and principles.
• Understanding of Good Automatic Manufacturing Practices issue 5 (GAMP 5), 21 CFR Part 11, Annex 11, and other industry best practices is required.

Education

• Bachelor's Degree in Engineering or Computer Science 

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 dynamic, fast-paced Customer Service Representative who will interact with customer 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, filling 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 offers a competitive salary and benefits package.

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 Chemical Engineering responsible for leading our growing business. TriLink BioTechnologies, a Maravai LifeSciences company, offers mRNA and oligo solutions as comprehensive CDMO services and an expansive stocked menu - to accelerate research, diagnostic, and therapeutic applications. TriLink has paved the way with industry-leading technology, consistent high quality, and ready access to expert scientific support.

Responsibilities

Qualifications

• A minimum of B.S. in a scientific discipline with and 10+ years of experience scaling up small molecule manufacturing processes
• Direct experience with the scale up of nucleosides and nucleoside triphosphates at scales greater than 10 kg per batch
• Well versed in various aspects of chromatography for nucleoside purifications
• Well versed in recrystallization, precipitation lyophilization and spray drying applications to small molecule manufacturing
• Well versed in 1H and 31P NMR, HPLC and LCMS
• BSc, MSc or PhD chemist or chemical engineering with 10+ years of experience with a particular focus and experience on synthetic organic chemistry in a large biotech or pharma setting
• Must be skilled at and committed to the development of other team members
• Strong understanding of operational discipline and cGMPs
• Experience with new facility startups and process technology transfers is preferred
• Should have excellent organizational skills and be able to multitask in a fast-paced environment with changing priorities.
• Excellent communication skills and ability to influence across multiple functions.

Education

• A minimum of B.S. in a scientific discipline with and 10+ years of experience scaling up small molecule manufacturing processes
• BSc, MSc or PhD chemist or chemical engineering with 10+ years of experience with a particular focus and experience on synthetic organic chemistry in a large biotech or pharma setting

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, 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 an IT Manager to join our growing team. The IT manager will be responsible for all the IT infrastructure, IT systems, IT security, and IT support needs of the users. This role will be the primary contact for all IT needs. This person will also develop and manage IT support staff.

Responsibilities

• Manage IT infrastructure and systems
• Develop and manage IT support staff
• Work with vendors for procurement needs
• Manage IT budget
• Collaborate with external partners to support the current IT environment
• Develop processes to streamline IT support functions
• Enforce IT policies and procedures
• Educate and train end-users on IT security

Qualifications

• 3-5 years as an IT Manager
• 3-5 years managing IT personnel
• 3-5 years working with vendors and partners
• Excellent verbal and written communication skills
• Strong analytical and problem-solving skills
• Bachelor’s in Information Systems or related discipline

Education

• Bachelor’s in Information Systems or related 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 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 looking for a Manufacturing Associate II, Material Movement/Batch Record Review. Manages raw material movement and final products on behalf of the department; coordinates with QA and Engineering for instrumentation that needs maintenance; coordinates with QA paperwork involving, but not limited to, the training records of team members, change requests for documentation, obtaining necessary batch record SOPs, and monthly log submissions. Performs final manufacturing review for good documentation practice errors; releases materials on behalf of the department; conducts internal inventory audit; adjusts inventory according to audit findings; coordinates with planning, scheduling, and materials management to ensure timely delivery of materials based off of a two-week schedule for production.

Responsibilities

• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; coordinating with materials management to pick materials and supplies
• Coordinates with QA for paperwork involving, but not limited to, the training records of team members, change requests for documentation, obtaining necessary batch record SOPs, and monthly log submissions
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; corresponding with the Engineering department for repairs.
• Reviews batch records for GDP errors perform final manufacturing review and releases material on behalf of the department
• Trains and mentors new team members.
• Manages material movement of raw materials and final products on behalf of the department, conducts internal inventory audit, adjusts inventory according to audit findings, coordinates with planning, scheduling, and materials management to ensure timely delivery of materials based on a two-week schedule for production
• Identifies key process bottlenecks and implements process improvements to minimize bottleneck

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 batch record review, HPLC purification of small molecules, materials management, 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
• Previous experience with an inventory management system
• 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, 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

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

Maravai LifeSciences is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

Maravai LifeSciences is looking for a NetSuite Business System Analyst. The NetSuite Business Systems Analyst would provide NetSuite expertise in the Finance modules to the business users. This role will be the primary contact for NetSuite Finance related questions. This person will also be responsible for training end-users and championing NetSuite within the organization

Responsibilities

• Serve as a business analyst to understand user needs and translate them into NetSuite requirements
• Be the subject matter expert on NetSuite Finance modules
• Train users on how to use NetSuite
• Create reports and dashboards in NetSuite
• Troubleshoot system process and systems issues within NetSuite
• Assist with the Finance close process

Qualifications

• 2-3 years of NetSuite business systems analyst experience
• 3-5 years of experience in NetSuite Finance module
• 2-3 years of NetSuite OneWorld experience
• 1-2 years of experience supporting Finance’s close process
• 3-5 years of experience creating reports and dashboards in NetSuite
• Strong analytical and problem-solving skills
• Bachelor’s in Information Systems or related discipline

Education

• Bachelor’s in Information Systems or related discipline

Maravai LifeSciences 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.

Maravai LifeSciences is an EEO employer.

Apply Now

Job Description

Maravai LifeSciences is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

Maravai LifeSciences is looking for a NetSuite Business System Analyst. The NetSuite Business Systems Analyst would provide NetSuite expertise in the Manufacturing modules to the business users. This role will be the primary contact for NetSuite Manufacturing related questions. This person will also be responsible for training end-users and championing NetSuite within the organization.

Responsibilities

• Serve as a business analyst to understand user needs and translate them into NetSuite requirements
• Be the subject matter expert on NetSuite Manufacturing modules
• Train users on how to use NetSuite
• Create reports and dashboards in NetSuite
• Troubleshoot system process and systems issues within NetSuite

Qualifications

• 2-3 years of NetSuite business systems analyst experience
• 3-5 years of experience in NetSuite Manufacturing modules
• 2-3 years of NetSuite OneWorld experience
• 2-3 years of inventory, planning, supply chain, and manufacturing systems experience
• 3-5 years of experience creating reports and dashboards in NetSuite
• Strong analytical and problem-solving skills
• Bachelor’s in Information Systems or related discipline

Education

• Bachelor’s in Information Systems or related discipline

Maravai LifeSciences 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.

Maravai LifeSciences 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 responsible for support of design and optimization of large-scale manufacturing processes for mRNA CDMO operations. This role will support and execute of tech transfer projects for the organization as TriLink continues to grow the business.

Responsibilities

• Executes cGMP CDMO tech transfer projects between external customers and internal manufacturing teams, specifically for mRNA active pharmaceutical ingredients
• Assists in development of scale-up production process of mRNA for clinical manufacture
• Works independently in the laboratory
• Responsible for designing and implementing experimental protocols, interpreting experimental results, and preparing internal reports summarizing the results

Qualifications

• A BS degree in a scientific field, preferably in Chemistry, Biochemistry, or Engineering 
• At least 3 years of relevant manufacturing laboratory experience
• Prior development experience of manufacturing processes compatible with cGMP manufacture of biological pharmaceuticals
• The ability to communicate clearly and precisely, both orally and in writing
• Ability to independently identify problems and effectively offer solutions to problems
• 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

• A BS degree in a scientific field, preferably in Chemistry, Biochemistry, or 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 Product Manager. This role will be responsible for the overall product management and forecasting of assigned portfolios. This position will work to evaluate sales performances by product and formulate corporate long-range plans, goals, and objectives to ensure optimum performance of products. The incumbent will work closely with Sales and Supply Chain to achieve the high levels of service our customers expect from TriLink BioTechnologies.

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 generic product portfolio
• Develops, communicates, and coordinates new product launch plans and strategy to the Sales & Marketing 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, Chemistry or Life Science. Master’s degree, MBA and/ or PhD is preferred
• 5-7 years of relevant work experience in the biopharmaceutical industry, with at least 2 years of product management experience in a CDMO setting
• Technical background in nucleic acid, CRISPR and gene therapy
• Experience with Netsuite and SalesForce preferred
• Experience in interpreting IMS data
• 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, Chemistry or Life Science. Master’s degree, 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 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 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 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 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 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 seeking a Senior Manufacturing Associate, Plasmid. Performing as a leader in the lab, 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 and perform chemical and enzymatic reactions following aseptic procedures. The role will document all actions using Good Documentation Practices.

Responsibilities

• Prepare for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies
• Provide written and verbal updates to supervisors or other department managers
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements
• Prepare production areas for initiation and/or changeover
• Write and execute batch records, author and review SOP’s, and maintain quality documents associated with manufacturing
• Train other manufacturing personnel
• Oversee installation, commission, and troubleshooting equipment as needed
• Interface with manufacturing support groups to align on production requirements
• Strong commitment to continuous improvement
• Perform as a leader in the laboratory space
•  Perform other related duties as required or assigned

Qualifications

• Bachelor’s degree in life sciences or related field
• Minimum of 5 years of relevant experience working in a professional lab
• Experience with plasmid DNA manufacturing processes strongly preferred
• Experience in a cGMP clean room environment preferred
• Ability to draft SOPs and support root cause investigations (i.e., deviations, NCMRs, CAPA)
• 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

• Bachelor’s degree 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 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