Careers

Job Description

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

Responsibilities

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

Qualifications

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

Education

• BS Degree in scientific area preferred

TriLink Biotechnologies offers a competitive salary and benefits package.

TriLink Biotechnologies is an EEO Employer.

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Job Description

TriLink Biotechnologies is seeking a Manufacturing Associate. This position will produce research and clinical grade components and products within ISO 5 and greater environments. The candidate will participate in the set-up, cleaning, operation, and maintenance of laboratory equipment; perform chemical and enzymatic reactions following asceptic procedures. The candidate must document all actions using GMP Good Documentation Practices. This position requires a candidate that can excel as a leader in the laboratory space. 

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.

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 in life sciences or related field.
• 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.
• Experience with mRNA and/or Oligonucleotide Synthesis a plus.

Education

• BS degree in life sciences or related field.

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Job Description

TriLink Biotechnologies is seeking a Manufacturing Associate II who will produce research and clinical TriLink Biotechnologies is seeking a Manufacturing Associate II. As part of the mRNA team at TriLink Biotechnologies, this individual will lead projects in a growing functional area. Focus of the role will include owning capacity, productivity, and continuous improvement efforts to meet long-term growth and profitability targets. The role will work closely with other Manufacturing areas, Quality, Planning, and R&D to develop, improve, and sustain production. 

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.

Responsibilities

• Perform routine production tasks, such as transcription, digest, PCR, and purification
• Review and approve manufacturing data and batch records
• Onboard and qualify new equipment and processes
• Execute change orders, deviations, CAPAs, and NCMRs
• Collaborate with development teams to lead improvement projects
• Maintain a safe and clean work environment by following current good manufacturing practices (cGMP), 5S, and standard operating procedures
• Answer employee questions regarding policies, benefits, and procedures, etc.

Qualifications

• BS degree in a scientific field, preferably in molecular biology with 3+ years life science industry experience
• Experience with 21 CFR 820, ICH Q7, ISO 9001, and /or ISO 13485 requirements a plus
• Experience with enterprise systems such as MES/NetSuite
• Experience with sample preparation for Next Gen Sequencing
• Experience with automation
• Strong multi-tasking abilities to complete activities in a fast-paced, deadline-driven environment
• Results driven self-starter
• 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 throughput environment
• Project Management skills and experience in managing multiple projects
• Proficient in the design and delivery of presentations
• Strong communication skills
• Proficiency with Microsoft Office programs and demonstrated ability to learn other applications as needed

Education

• BS degree in life sciences or related field.

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Job Description

TriLink BioTechnologies is a contract manufacturing organization providing research, diagnostic and clinical grade process development and manufacturing services to global biotechnology and pharmaceutical companies for modified nucleic acid products.

TriLink Biotechnologies is seeking an NPI Planner reporting into our Operations team. The planner will mainly support various programs including GMP, New Product Introduction (NPI), and development. The planner will interface regularly with Sales, Manufacturing, Materials Management, Planning and Procurement. Customer requirements will drive scheduling tasks, build plan and material requirements. This role is in a fast pace, dynamic environment in support of company growth.

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 retirement plan.

TriLink Biotech is an EEO Employer

Responsibilities

• Create, maintain and execute detailed build plans to meet customer requirements and on-time delivery.
• Understand production capacity and schedule work orders to maximize use of capacity resources.
• Review of safety stock and reorder points.
• Develop material plan to ensure all materials are available to start production build.
• Review, resolve and escalate issues that impact plan completion.
• Participate in batch record review to understand yield and manufacturing scale.
• Assist creating Bills of Materials (BOM) for new custom builds.
• Resolve work order discrepancies.
• Ability to problem solve and strive for continuous improvement.
• Experience with expiry, sell-by date and kanban process a plus.
• Create adhoc material run-out analysis during material shortage situations.
• Planner will need to be comfortable with manual planning, while working in a fast-pace environment, and capable of learning on the job and able to switch between tasks.
• Qualifications

Qualifications

• A Bachelor’s of Science in a scientific field or equivalent life science/biotech experience.
• 3-5 years of planning experience preferred.
• GMP experience preferred.
• NetSuite or equivalent ERP system experience highly preferred.
• Planning experience in development or NPI setting preferred.
• Highly proficient in Microsoft Office Suite, especially Excel (vlookup, sumif, pivot table).
• Understanding of BOM structure and be able to perform unit conversions.
• Detail-oriented with strong written and verbal communication skills.
• Ability to multi-task, be a team player, and be able to organize and prioritize multiple tasks.

Education

• A Bachelor’s of Science in a scientific field or equivalent life science/biotech experience.

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Job Description

TriLink Biotechnologies is seeking a Quality Specialist, Audits responsible for managing Trilink's audit program including: hosting customer audits, preparing for ISO 9001 audits, coordinating and conducting internal and supplier audits. Ensure compliance with applicable domestic and international standards. This is a hands-on auditing position. Position also requires working as part of the Quality Assurance team and the rest of the organization to implement improvements resulting from audit findings. 

Responsibilities

• Manage TriLink's customer audit program. Coordinate with customer and TriLink account team to schedule appropriate timing and length of audits based on customer's quality agreement.
• Prepare for and host customer audits, including preparing documents and working with personnel to prepare for and participate in the audit.
• Work with appropriate functions to respond to audit findings.
• Develop annual supplier audit schedule based on supplier performance, business risk, etc.
• Conduct supplier audits including scheduling, agenda preparation, and report preparation.
• Track supplier response to audit findings and manage through to completion.
• Prepare annual internal audit schedule.
• Participate on internal audit team and support external audits.
• Partner with other Maravai quality groups to assist in their internal audit program.
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
• Assist Quality Department in other activities as assigned

Qualifications

• BS Degree in scientific discipline
• Quality professional with a minimum of 5 years relevant experience in a life science industry
• Requires knowledge of cGMPs regulations (e.g. ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820), and ISO 9001 (or ISO 13485) regulations
• Strong verbal and written communication skills
• Demonstrated audit experience against ISO9001, ISO13485, or FDA regulations
• Lead auditor training for ISO9001 or ISO13485 required. CQA certification preferred.
• Strong interpersonal, teamwork, and customer interfacing skills
• Strong problem-solving skills
• Self-motivated and able to organize and prioritize multiple tasks
• Able to identify quality issues/discrepancies and effectively resolve discrepancies within the organization

Education

• BS Degree in scientific discipline

TriLink Biotechnologies offers a competitive salary and benefits package.

TriLink Biotechnologies is an EEO Employer.

Apply Now

Job Description

TriLink Biotechnologies is seeking a Senior, Manufacturing Associate. This position will be an in-lab leader in the production of research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing chemical and enzymatic reactions; following aseptic procedures; and documenting actions. 

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.

Responsibilities

• Leads by example with a high level of compliance with regard to cGMP regulations
• Leads the development, implementation, assessment and improvement of laboratory processes, procedures and controls.
• Facilitate continuous improvement within the laboratory
• Leads/assists with laboratory problem solving projects and investigations
• 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 current good manufacturing practices (cGMP), and 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.
• Updates job knowledge by participating in training opportunities.
• Writes, edits and reviews batch records and SOPs.
• Participate is maintenance and cleaning of the cleanroom facilities and any other duties assigned.
• Participates in the training of personnel.

Qualifications

• A Bachelor’s degree in life sciences or related field and 5 - 7 years of relevant GMP manufacturing laboratory experience or an MS degree and 3 - 5 years of experience
• Experience with Standard Operating Procedures
• Experience with Oligonucleotide Synthesis a plus
• Solid chromatographic and spectroscopic method development and trouble shooting skills
• Ability to work in a clean room environment
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Effectively build and maintain positive relationships with peers and colleagues across the organization

Education

• A Bachelor’s degree in life sciences or related field and 5 - 7 years of relevant GMP manufacturing laboratory experience or an MS degree and 3 - 5 years of experience

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Job Description

TriLink Biotechnologies is seeking a Senior QC Associate. As part of the QC team at TriLink Biotechnologies, this individual will be responsible for 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

• 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
• Demonstrated 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

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