Careers

Job Description

TriLink Biotechnologies is seeking Buyer II to provide procurement support with various project requirements as delegated by the Sr. Manager of Procurement & Strategic Sourcing. This individual will be responsible for placing orders for materials and services to be incorporated into Manufacturing and/or Operations, including handling communications with suppliers to ensure timely delivery at a competitive price point. 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 a retirement plan.

TriLink is an EEO Employer.

Responsibilities

• Review purchase requisitions, obtain quotes, examine bids, make awards, develop new supply sources as needed
• Work with Planning to manage long term production schedules to ensure material readiness
• Generate purchase orders to support all business requirements through various request methods, NetSuite, zero picks, reorder points, emails and verbal requests in a timely manner
• Responsible for expediting, following-up and communicating estimated delivery dates for open purchase orders to ensure timely delivery and appropriate production scheduling
• Represents Procurement department in addressing and/or resolving issues with other departments
• Manages and facilitates the closure of all open purchase orders pending approvals
• Maintain professional relationships with suppliers by providing adequate lead times and communicating updates to all end-users
• Successfully contribute to cost saving corporate initiatives through various bidding, supplier consolidation, and material standardization activities
• Evaluates assigned general ledgers account accuracy for all submitted and generated purchase orders
• Works closely with Accounts Payable to resolve all invoice issues
• Interacts with Receiving Department and suppliers to resolve receiving discrepancies and arranging returns
• Responsible for procuring inventory purchases from approved suppliers
• Communicate process issues and present streamlining and process solutions/li>
• Assist with root cause analysis for all material shortagess
• May provide minimal guidance with training lower level buyers
• Perform other related duties as required or assigned

Qualifications

• Minimum of 5 years of relevant experience in similar biotechnology/life science industry
• Experience with ERP/MRP systems required, NetSuite expertise preferred
• Proficient in Microsoft Office
• Expertise with effective negotiation and managing suppliers
• Working knowledge of Accounting practices
• Completes work assigned in a reliable, consistent manner while working successfully as an individual and within a team environment
• Personable, good listener, and with excellent written and verbal communication skills
• Self-motivated and able to organize and prioritize multiple tasks

Education

• Minimum of 5 years of relevant experience in similar biotechnology/life science industry

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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.

Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.

TriLink Biotechnologies is seeking a Facilities Engineer to join our team. The Facilities Engineer 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.

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

Qualifications

• 2 year Degree, technical school degree or equivalent experience
• HVAC Repair Training, preferred
• General electrical wiring/installation training, preferred
• Minimum 5 years experience as a Maintenance Mechanic, Facilities Technician, 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 troubleshooting skills- electrical / mechanical
• GMP documentation Skills
• Must be able to coordinate multiple contract services simultaneously
• Good communication and organizational Skills
• Proficient in all Microsoft Office applications
• Must be able to lift 50 pounds
• Exposure to elements (i.e. hot weather, cold weather, precipitation) for brief periods.
• Operate computer-controlled equipment which requires a combination of standing, sitting, and walking to and from the operator interface terminal
• Required to work around live electrical circuits and mechanical devices in the execution of their duties

Education

• 2 year Degree, technical school degree or equivalent experience
• HVAC Repair Training, preferred

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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.

Apply Now

Job Description

TriLink Biotechnologies is seeking a Manufacturing Manager as part of the Leadership team at TriLink Biotechnologies, this individual will lead 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

• Review and approve manufacturing data and batch records.
• Plan and manage capacity (Equipment and Labor) to meet yearly demand.
• Execute, Change Orders, Deviations CAPA's and NCMR's.
• Collaborate with development teams to lead improvement projects.
• Develop tools and reports to trend and monitor manufacturing operations process health (Quality, rework, OTD) to provide and drive actionable information.
• Hire and retain key talent to meet strategic and tactical goals and KPI's.
• Maintains safe and clean work environment by following current good manufacturing practices (cGMP), 5S and standard operating procedures.

Qualifications

• A Bachelor’s of Science in a scientific field, preferably in Chemistry or Biochemistry with 7+ years industry experience and 3+ years supervisory experience leading teams.
• Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus.
• Experience with enterprise systems such as MES/JDE etc.
• Strong multitasking 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.

Education

• A Bachelor’s of Science in a scientific field, preferably in Chemistry or Biochemistry with 7+ years industry experience and 3+ years supervisory experience leading teams.

Apply Now

Job Description

TriLink Biotechnologies is seeking a Production Manager, Shared Services. This role will lead and develop a growing functional area (Shared Services) within manufacturing operations, specifically involving buffer formulation, laboratory support, fill/finish activities, and kitting.  Focus of the role will include owning resource scheduling, identifying opportunities for improvement within the team’s processes, and developing a road map to increase capacity and scope expansion.  This role will serve as a point of contact with Manufacturing, Release, and Shipping teams, while developing, improving, and sustaining production to help take us to the next level in our growth cycle.

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

• Plan and manage long term buffer, lab support, and fill/finish schedules to meet customer requirements and best utilize manufacturing capability.
• Comprehensive review of process workflows to identify and implement continuous improvement opportunities.
• 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 a related field, with 5+ years of relevant experience.
• Experience as a cross-functional leader with demonstrated results in life sciences/chemistry manufacturing operations.
• Demonstrated ability to coach, develop, and mentor team members, with 3+ years of people leadership experience.
• Ability to draft SOPs and support root cause investigations (i.e., deviations, NCMRs, CAPA).
• Ability to hire and train operators to perform essential production functions, including generation and maintenance of training matrix and job descriptions.
• Experience with ERP/MRP systems required; NetSuite expertise strongly preferred.
• Proficient in Microsoft Office.
• Experience with cGMP preferred.
• Experience scheduling both non-recurring and recurring production needs.
• Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability to manage stress and balance competing demands in a high throughput environment.

Education

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

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 Sr. QC Associate. This individual will be charged with leading transfer and sustaining activities for QC functional assays, both from internal development, as well as from external customers. The role will work closely with Manufacturing, Quality, R&D, commercial, and our external customers, to develop, transfer, and sustain QC activities to help us take the next steps forward in our growth cycle. 

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

• Partner with internal and external customers to transfer, qualify, and/or validate new assays and methods
• Troubleshoot and improve existing functional assays to drive improvements in first pass test rates as well as provide feedback for future QC assay design.
• Design, propose, and prioritize scopes of work for QC transfer, validation, stability, and continuous improvement projects and drive these projects to completion in partnership with cross-functional areas.

Qualifications

• Bachelors of Science or higher in chemistry, biochemistry, molecular biology, bioengineering, or related field with 10+ years life science industry experience.
• Experience with method design and transfer of analytical or functional assays.
• Experience with method, spreadsheet, and software qualification and validation.
• Experience with equipment/enterprise system integrations such as LIMS integrations with laboratory equipment.
• Advanced skills in Microsoft applications such as Word, Excel, and Project.
• Familiar with statistics and data analysis tools such as JMP, R, or Matlab.
• Experience with 21 CFR 820, ICH Q&, ISO 9001, and /or ISO 13485 requirements a plus.
• Strong multi-tasking abilities to complete activities in a fast-paced, deadline-driven environment.
• Results driven self-starter.
• Ability to manage stress ad balance competing demands in a high throughput environment.

Education

• Bachelors of Science or higher in chemistry, biochemistry, molecular biology, bioengineering, or related field.

Apply Now