Careers

Job Description

TriLink BioTechnologies is seeking an Associate Director, Program Management who will oversee a wide variety of projects that support all functions. The programs and projects that this role will manage are cross-functional, multi-site, complex, and can require overseeing outside contractors. In this role, the AD, Program Management, will develop solutions in collaboration with senior leadership. This highly visible role will manage customer programs, drive strategic projects and internal initiatives. This position will require the individual to interact and build productive working relationships with site senior leadership and employees at multiple levels.

Responsibilities

• Creates and manages customer centric programs to support clients who contracted services with the organization
• Manages multiple complex cross-functional programs and / or projects, simultaneously.
• Leads high-level, cross-functional teams. Ensures project objectives are aligned with site goals whenever possible.
• Provides value to project leads and team members as a thought partner by developing innovative solutions and utilizing project management best practices to ensure project execution (to include: establishing priorities, defining deliverables, and planning activities to deliver on project goals and objectives).
• Seeks to improve processes and performance, where applicable. Facilitates meetings and workshops.
• Ensures project roles and responsibilities are clearly defined.
• Builds, maintains, and controls project plans highlighting dependencies and the critical path
• Identifies and documents risks and co-develops mitigation plans. Organizes and facilitates project team meetings, develops meeting agendas, issues meeting minutes, and tracks action items to completion. Communicates project status, risks, and mitigation plans to appropriate stakeholders to executive leadership.
• Maintains and logically organizes project related documentation (e.g. timelines, minutes, related documents, etc.) for collaboration.
• Polished presenter, able to influence at all levels of the organization.
• Refined organization and planning skills.
• Ability to self-start and be versatile in a dynamic environment.
• Ability to maintain confidentiality with sensitive information.

Qualifications

• 10+ years of project management or related experience.
• Significant project management experience within the biopharma or life sciences industry with an emphasis on management of customer programs.
• Flexible strategic thinker, possessing the ability to adapt to changing project scope and provide solutions based on thorough analysis.
• Experience managing diverse working groups.
• Strong written and verbal communication skills.

Education

• 10+ years of project management or related experience.
• Significant project management experience within the biopharma or life sciences industry with an emphasis on management of customer programs.

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 seeking a dynamic Director, Product Management to develop and drive our growing business by designing the strategy and technical messaging for our global portfolio of products and services. This role will include the global commercialization of new products and services and ongoing portfolio management in support of corporate business objectives.

Globally focused in a fast-paced, high growth environment and in collaboration with the Vice President of Commercial Operations and the Commercial team, this candidate will possess the ability and experience to drive and execute these responsibilities with minimal management oversight. Ultimately, as the Director, Product Management, the candidate will help to develop and drive the product management process and manage the day-to-day business needs.

The Director, Product Management will collaborate with cross-functional Technical Leaders, Marketing team members, Business Development Leaders, and Customers on the following activities: develop roadmap for products & services, conduct market research, monitor competitive activities, conduct competitive analysis, Voice of the Customer development, launch new products, education and training, establish pricing strategies, and tradeshow support. The ideal candidate is a results-oriented leader who is motivated by optimizing profit as well as meeting/exceeding marketing, financial and corporate growth objectives.

Responsibilities

• Design and define the company’s global products & service portfolio strategy with business partners
• Lead the Voice of the Customer efforts by gathering and prioritizing customer needs internal and external with supporting data driven methodologies
• Evaluate competitors and the market for capability-oriented emerging development and technology trends and work with business development on potential product enhancement opportunities
• Lead key sales situations for the product such as customer engagements
• Own revenue and margin targets within procedure portfolios
• Develop global product revenue forecast and margin targets
• Build and maintain competitive intelligence gathering and analysis that informs portfolio strategy
• Provide technical leadership to the Commercial team on product positioning.
• Partner with marketing on channel marketing campaigns, core content development, messaging and positioning.
• Ensure technical alignment between internal and external stakeholders
• Build and execute robust process for new product/service development and launch.
• Communicate all market requirements for current and future products/services (min. 2-3 years out)
• Execute measurable strategies to drive consistent and profitable growth of products
• Partner with the cross functional team to ensure cohesive and clear strategic plans.
• Analyze ongoing brand performance, driving alignment with full cross functional team. Communicate opportunities and gaps to peers and to management, offering actionable recommendations.
• Assess market information needs relevant to development or monitoring of strategies and implement market research projects to address such issues
• Provide support as required for maintenance of intellectual property including trademarks for portfolio of products and services.

Qualifications

• BS in Life Science field required. Advanced degree (PhD, MBA) preferred
• 10+ years of related product management experience in the life science / biotech industry with knowledge of DNA / RNA products and services
• Experience working in a CDMO/GMP environment required
• Knowledge of key BioPharma, Life Science and Diagnostic accounts throughout North America and Europe is required (similar knowledge in Asia is preferred, but not critical).
• Ability to develop and execute strategic portfolio plan including new products & services roadmap, technical positioning and product life cycle management.
• Demonstrated confident, team player with ability to coordinate multiple projects in a fast paced and deadline driven environment
• Problem solver with the ability to effectively communicate solutions
• Excellent written and verbal communication skills with the ability to speak / collaborate effectively with external clients/partners and internal teams
• Comfortable leading meetings and drafting communications for senior leadership and stakeholders
• Ability to demonstrate a customer-service orientation with the ability to translate business goals into product requirements
• Strong business acumen.
• Adaptable and flexible, with a passion for driving organization change
• Both data driven and intuitive; analytical and creative
• Strong working knowledge of MS Office (Word, Excel and PowerPoint)
• 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 seeking an Environmental Health and Safety (EHS) Manager to develop and execute EHS programs for TriLink Biotechnologies and help lead companywide EHS projects as needed. The primary duties will involve effectively managing and mitigating exposure while promoting a safe workplace for employees and ensure compliance with applicable environmental and safety regulations by developing and maintaining a comprehensive EHS program.

Responsibilities

• Ensure that the EHS programs meet all federal, state and local regulatory, reporting, permitting and licensing requirements
• Oversee regular trainings, laboratory safety checks, and general inspections to ensure compliance with occupational health and safety standards 
• Continuously review and improve new health and safety policies and procedures i.e., biosafety, chemical safety, ergonomics, illness and injury prevention, emergency preparedness, hazardous waste, etc.
• Analyze and maintain safety metrics, reports, records, training documents, CERS, etc. to ensure compliance with all regulatory agencies
• Assist with investigation of injuries/illnesses, near-misses and environmental incidents and provide support for corrective action plans
• Manage emergency procedures such as mock and real alarm drills
• Promote safety culture in the workplace and actively participate in safety committee meetings to encourage team members to take ownership of their areas
• Technical experience in and knowledge of biotechnology, research and development, or laboratory setting is required.

Qualifications

Experience

• Minimum 10 years of EH&S experience.
• LifeScience and laboratory focus preferred
• Chemical laboratory safety programs
• Hazardous waste and hazardous chemical management
• Powered equipment and warehouse experience
• Experience interacting with varying regulatory agencies and reporting requirements of each i.e., CERS, FPB-500, etc.
• In depth understanding of CAL-OSHA, CAL-EPA, ISO, DOT, NFPA and workers compensation regulations

Knowledge, Skills, 

• Abilities:A people-oriented leadership style that thrives in a fast-paced, dynamic workplace
• Excellent interpersonal and communication skills
• Excellent oral and written communication skills
• Demonstrate a positive and approachable demeanor
• Safety management preferred
• Certified Safety Professional (CSP) and/or certified Industrial Hygienist (CIH) preferred
• Member of the NSC, ASSP, NAEM or other similar entities

Education

• B.S. in Environmental/Occupational Health and Safety, Physical and/or Lifescience or Certification such as CSP, CHMM, CIH; Master degree 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 who is responsible for facilities under management. 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

• Performs periodic inspections of HVAC systems and their components to evaluate conditition, identify necessary repairs and recommend preventive maintenance
• Diagnose causes of HVAC systems problems and identify solutions
• Maintains, operates, and troubleshoots air handlers, VAV boxes, and all associated air exchanges, pumps, controls and monitoring, etc.
• Maintains and operates a computerized maintenance program
• Ensures all building equipment and systems are operated in a safe manner and are in compliance with all applicable codes and regulations
• Supports in small projects and minor repairs, such as patching and painting, tiling, flooring, door hardware, minor plumbing and electrical repairs, carpentry and furniture moves
• Responds to minor janitorial requirements as well as maintaining of the work areas and technical rooms
• Responsible for equipment startup, monitoring, and efficient operations
• Responds to facilities complaints and assists other trades as necessary
• Reads and interprets drawings and control schematics
• Assists other trades as assigned
• wiCompletes all other tasks required by his immediate supervisor

Qualifications

• 2 yr degree from a technical school or equivalent
• HVAC Repair Training preferred
• General electrical wiring/installation training, preferred
• Minimum 5 yrs experience as a Maintenance Mechanic, Facilities Techncian, or with an equivalent trade
• Experience working in a GMP Environment and completion of GMP documentation
• OSHA safe work practices
• Building Management System Experience (Siemens, Johnson Controls) a plus
• Good trouble-shooting skills (electrical/mechanical)
• GMP documentation skills
• Must be able to coordinate multiple contract services simultaneously
• Good communication and organization skills
• Proficient in all Microsoft Office applications
• Must be able to lift 50 lbs
• Exposure to elements (hot weather, cold weather, precipitation) for brief periods
• Operate computer-controlled equipment which requires a combination of standing, sitting, and walking
• Required to work around live electrical circuits and mechanical devices in the execution of duties

Education

• 2 yr degree from a technical school or equivalent
• 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 Manufacturing Associate I, GMP. 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. 

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.

Qualifications

• BS degree or equivalent in life sciences or related field.
• Experience in a cGMP clean room environment preferred.
• Excellent written and verbal communication skills.
• Solid organizational skills, detail-orientated, and demonstrated problem-solving abilities.
• Self-starter, able to organize and prioritize multiple tasks.
• Experience with mRNA and/or Oligonucleotide Synthesis a plus.

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 responsible for producing research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; performing HPLC purification; documenting actions.

SHIFTS AVAILABLE:
2 p.m. to 11 p.m. M-F

Responsibilities

• Prepares for production by reviewing production schedule; reviewing specifications; calculating requirements; assembling materials and supplies.
• Performs dilutions and spectrophotometric readings to quantify compounds.
• Operates and maintains rotary evaporator to concentrate compounds.
• Operates and maintains HPLC/UPLC equipment for purification and analytical QC.
• Performs wet chemistry reactions.
• Maintains 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.
• Updates job knowledge by participating in training opportunities.

Qualifications

• A B.S. Degree in a scientific field, preferably in Chemistry related field. 
• At least 3 years of relevant manufacturing laboratory experience, preferably with HPLC purification
• Experience with Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks

Education

• A B.S. Degree in a scientific field, preferably 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.

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 seeking Quality Assurance Associate II to join our growing team. This role is responsible for review and approval of material release specifications, raw materials, intermediates and consumables in compliance with cGMP regulatory requirements and ISO standards.  This role will provide support for other functions performed by QA operations group.

Responsibilities

• Responsible for conducting raw material, component, in-process inspection and release in conformance to established product requirements.
• Responsible for assigning lot numbers, expiration dates, logging all materials in database, and labeling materials appropriately.
• Review analytical test reports, Certificates of Analysis, and Certificates of Origin in support of material specification approval and release.
• Sample raw materials according to current procedures for conformity with specifications and approve or reject accordingly.
• Develop raw material release specifications and associated documentation.
• Oversee and assist in segregating non-conforming materials as required.
• Routinely review specifications/standards for compliance to current regulatory requirements.
• Provide backup support for final product release, non-conformance reports and other QA functions as required.

Qualifications

• BS Degree or equivalent in a scientific discipline
• Quality professional with 2-5 years of hands on experience in material inspection and release in a life science industry.
• Detail oriented professional with strong verbal and written communication skills.
• Good computer skills with working knowledge of MS office suite and Adobe Acrobat.
• Self-motivated and able to organize and prioritize multiple tasks.
• Identify quality issues/discrepancies and effectively resolve discrepancies within organization.

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 seeking a Quality Control Lead. The Group Lead will provide on-the-job leadership for our growing QC operations responsibilities having direct oversite of QC team members and ensuring the team is following proper procedures to meet quality and scheduling objectives. The Group Lead will also assist in training, drafting deviations and drafting technical documents for QC processes. This person will be responsible for leading the team in responsibilities pertaining to Functional Assays Method Validation/Qualification and Method Transfer from internal development as well as from external customers. The role also requires to sustain the activities for QC Functional to support Assays for the core Manufacturing, Quality, R&D and GMP. This successful candidate will thrive in a fast-paced environment and will serve as a technical expert and in lab support for QC Functional for all equipment and method related needs.

Responsibilities

• Provide on the job leadership to the QC team.
• Partner with internal and external customers to transfer, qualify, and/or validate new assays and methods.
• Independently conducts analyses and interprets results.
• Set up, troubleshoot, and make adjustments to laboratory equipment.
• Performs routine to complex laboratory analyses and experiments with no supervision.
• Transfer, modify, and improve analytical methods for Slot Blot, Fragment Analyzer, BioAnalyzer, Capillary Electrophoresis, qPCR and etc.
• Serves as a technical lead on projects and provides direction to various levels of QC Associates.
• Compose Standard Operating Procedures (SOPs), Analytical Protocols, Analytical Reports and GMP documents.
• Method and system qualifications.

Qualifications

• B.S. or advanced degree in Biology or a related science required with a minimum of eight (8) years experience on analytical bench working with analytical method qualification/validation and method transfer experience. Demostrated fundamental knowledge of various instruments and wet chemical analytical techniques
• Solid understanding of theory and operating principles techniques of Slot Blot, Fragment Analyzer, BioAnalyzer, Capillary Electrophoresis, qPCR and etc.
• Strong GMP and GLP background is highly desirable.
• Experience with ISO 9001 / 13485 preferred

Education

• B.S. or advanced degree in Biology or a related science required with a minimum of eight (8) years experience on analytical bench working with analytical method qualification/validation and method transfer experience. Demostrated fundamental knowledge of various instruments and wet chemical analytical techniques

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 seeking a Senior Quality Associate.   This person will be responsible for coordinating  daily analytical testing, outsourced testing with contract labs, and routine data review of test results.  The successful candidate will thrive in a flexible fast-paced environment and demonstrate excellent attention to detail and prioritizing skills.

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 a 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. are highly desirable

Education

• B.S. or advanced degree in chemistry or biology or a 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