Careers

Job Description

TriLink Biotechnologies is seeking a Director, Business Development professional responsible for driving revenue via direct client interactions to support the company’s annual growth objectives. This role will drive 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 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 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 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. 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 with 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.
• Ability to work independently in a home office.

Education

• Degree in Biology, Cellular Biology, Molecular Biology, Genomics, Biochemistry or related discipline. 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 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 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 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. 

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.

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 Manufacturing Associate II. This role produces research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; documenting actions.

Positions Avalible:

11 a.m. – 8 p.m. Shift

8 a.m. – 5 p.m. Shift

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 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.

Qualifications

• A Bachelor’s of Science in a scientific field, preferably in Chemistry. 
• At least 2 years of relevant manufacturing laboratory experience
• Experience with Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks

Education

• BS 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 seeking a Manufacturing Associate II for its bioconjugation group. The Manufacturing Associate II is responsible for manufacturing bioconjugation products using routine and advanced procedures and documenting all work in production batch records using established good documentation practices. The Manufacturing Associate II operates and maintains a variety of laboratory equipment. Knowledge of general laboratory safety, as well as experience with techniques such as spectrophotometry, protein labeling and conjugation, SDS-PAGE, and chromatography are required. The Manufacturing Associate II works under general supervision on assigned tasks and can effectively train junior staff.

Responsibilities

• Prepare for production by reviewing production schedule; study and clarify specifications; calculate job requirements; assemble materials and supplies
• Manufacture bioconjugates according to ISO 9001:2015 requirements and established procedures
• Perform column purification/chromatography, biomolecule conjugations, and kit reagent preparation using manual and automated procedures
• Perform in-process and final QC testing as required
• Assist in product and process development efforts, including scale-up optimization
• Draft and revise manufacturing documents
• Keep equipment operating by following documented maintenance and operating instructions, and troubleshooting problems
• Document production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices
• Update job knowledge by participating in training opportunities
• Perform other duties as assigned

Qualifications

• BS or BA degree in Chemistry, Biochemistry, Biology, or equivalent discipline
• At least 2 years of relevant manufacturing laboratory experience
• Experience with bioconjugation strongly preferred
• Experience with standard operating procedures and ISO 9001 standards
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Able to meet multiple deadlines and work under time constraints

Education

• BS or BA degree in Chemistry, Biochemistry, Biology, or equivalent 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 Material Handler I. This position will help maintain warehouse stock and assist in fulfilling orders in order to meet long-term growth and profitability targets.  Preference will be given to candidates available to work overtime and/or weekend hours during the busier times of the year and able to lift up to 50-60 pounds at a time. This role will serve as a point of contact for daily execution within the organization and work closely with Manufacturing, Operations, Quality, R&D, and Commercial to sustain production and help us take the next steps forward in our high-growth cycle.

Responsibilities

• Prepare outgoing shipments to ensure shipments meet Quality specifications. Responsible for verifying shipments meet customer order requirements, creating shipping labels, and packaging of finished goods
• Coordinate international shipping and fulfillment of customs documentation as needed
• Receive materials, parts, and supplies; verify paperwork and store in appropriate locations. Issue material, parts, and supplies; fulfill production orders as required
• Maintain inventory by identifying, labeling, and placing materials and supplies in stock; recording location of inventory
• Locates materials and supplies by pulling and verifying materials and supplies listed on production orders
• Maintain safety in all areas
• Maintain all inventory in a clean, organized, clearly labeled, and accessible system
• Contributes to team effort by accomplishing related results as needed
• Perform other related duties as required or assigned

Qualifications

• Minimum of GED degree, or equivalent, with minimum of 0-2 years of relevant experience (Shipping, Receiving, and/or inventory control)
• Experience with ERP systems, such as NetSuite, and Microsoft Office products strongly preferred
• 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 work well in a team environment
• Ability to work in a fast-paced environment with a positive attitude
• Ability to follow detailed instructions, maintain accurate records and notes, and the ability to carry out assignments in a thorough, conscientious fashion

Education

• Minimum of GED degree, or equivalent, with minimum of 0-2 years of relevant experience (Shipping, Receiving, and/or inventory control)

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 Biotechnologies is an EEO Employer.

Apply Now

Job Description

TriLink Biotechnologies is seeking a Senior Manager, Quality Systems responsible for managing the company Quality Management System, including CAPA, non-conformances, deviations, complaint handling, internal audit program, document and record control, training, metric reporting, and product release. This includes the development, implementation, and monitoring of quality programs and policies that ensure the development manufacture of products in compliance with company policies and procedures and applicable domestic and international standards and regulations.

Responsibilities

• Manage the company's Quality Systems to support development, manufacture, and distribution of API's and research grade products in compliance with company policies and procedures and applicable domestic and international standards and regulations.
• Oversee the CAPA program and ensure investigations are thoroughly conducted and complete with root cause, corrections, and corrective/preventive actions identified. Provide quality review and approval of CAPAs. Track status to completion, including CAPA effectiveness. Implement use of quality tools, such as 5-Whys, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Manage the non-conformance, deviation, and complaint handling systems, including quality review and approval.
• Lead the organization Quality Review Board to ensure cross-functional review of issues and timely completion of actions.
• Manage the Document Control function, including record control and training, and ensure change controls are completed and approved timely.
• Manage the internal audit program and conduct compliance audits in alignment with company's policies. Host external customer audits.
• Manage the compilation, review, and trending of quality system metrics for Quality Review Board, Management Review Board, and operational metric reporting.
• Establish, implement, and maintain continuous improvement of quality processes and systems that assure compliance with applicable regulations and standards.
• Work with R&D, manufacturing, quality, technical support, materials management, etc. to identify opportunities for improvement. Manage quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates.
• Supervise subordinate employees, including training, employee development, and performance management.
• Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.

Qualifications

• BS Degree in scientific discipline.
• Quality professional with a minimum of 8 years’ experience in a quality management capacity in a life science industry.
• Minimum of 5 years of leadership experience.
• Requires knowledge of cGMPs regulations (21 CFR 210,211 or 21 CFR 820), ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients (API), and ISO 9001 (or ISO 13485) regulations.
• Familiar with cleanroom operations (e.g. operating in a clean room, EM monitoring, validation, etc.)
• Requires knowledge of ISO 9001, ICH Q7, 21 CFR 820, and/or 21 CFR 210/211.
• Strong verbal and written communication skills.
• Strong interpersonal 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.
• Experience in conducting audits and supporting inspection readiness activities resulting in successful inspections.
• Travel required 10-20%

Education

• BS Degree in 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 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

Apply Now

Job Description

TriLink Biotechnologies is seeking a Senior Material Handler. This position will help maintain warehouse stock and assist in fulfilling orders in order to meet long-term growth and profitability targets.  Preference will be given to candidates available to work overtime and/or weekend hours during the busier times of the year and able to lift up to 50-60 pounds at a time. This role will serve as a point of contact for daily execution within the organization and work closely with Manufacturing, Operations, Quality, R&D, and Commercial to sustain production and help us take the next steps forward in our high-growth cycle.

Responsibilities

• Assist in running an efficient warehouse operation that can fulfill operational and customer demands while maintaining metrics
• Provide a strong floor presence and understanding of warehouse processes in order to set an example for others to follow
• Prepare outgoing shipments to ensure shipments meet Quality specifications. Responsible for verifying shipments meet customer order requirements, creating shipping labels, and packaging of finished goods
• Coordinate international shipping and fulfillment of customs documentation as needed
• Receive materials, parts, and supplies; verify paperwork and store in appropriate locations. Issue material, parts, and supplies; fulfill production orders as required
• Assist in reviewing pick sheets based on internal demand and pulling the correct raw materials and supplies
• Work closely with Planning, Procurement, and Warehouse groups to monitor supply levels and submit purchasing recommendations on a regular basis
• Promote safety in all areas
• Maintain all inventory in a clean, organized, clearly labeled, and accessible system
• Assist and lead assigned activities associated with warehouse operations
• Assist with determining staffing levels and assigning workload; to include training and cross-training of warehouse staff
• Motivate staff within assigned area, ensuring tasks are completed and procedures followed
• Perform other related duties as required or assigned

Qualifications

• High school diploma or equivalent, 7+ years of relevant experience or bachelor’s degree with a minimum 5 years of relevant experience
• Experience with ERP systems, such as NetSuite, and Microsoft Office products required
• 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

• High school diploma or equivalent, 7+ years of relevant experience or bachelor’s degree with a minimum 5 years of relevant experience

TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.

TriLink is an EEO Employer.

Apply Now

Job Description

TriLink Biotechnologies is seeking a Senior Quality Associate to join our team. The Senior Quality Associate is responsible for production batch record review and final product release from Quality Assurance. This role will ensure that final products meet all specifications prior to final product release by QA and is responsible for all aspects of Nonconforming Material Reports associated with final product and raw material.

Responsibilities

• Verification of final product, batch records, labels and associated certificates for compliance, accuracy and completeness. Verification of final product testing results with specifications to ensure all release criteria are met. Release and approval of final product from Quality Assurance.
• Initiation of deviations, quarantine requests or non-conforming material reports due to a non-conformance. Routing of information to appropriate departments to facilitate timely responses to non-conformances.
• Generate, review, and revise quality system procedures, as appropriate.
• Support other quality systems including CAPA, complaint handling, deviations, training, etc.
• Assure compliance with all in-house or external specifications to standards.
• Support the Raw Material Release function as required.

Qualifications

• BS Degree or equivalent in a scientific discipline
• A minimum of 3 Years of experience in a quality role in the biotechnology industry
• Strong organizational skills and detail-oriented
• Strong communication, interpersonal skills, and team player
• Knowledge of ISO 9001 and ICH Q7 requirements
• Ability to work independently and prioritize tasks
• Comfortable in a fast paced, stimulating and customer-focused environment

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.

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