TriLink BioTechnologies is seeking a Senior Manufacturing Associate for its bioconjugation group. The Senior Manufacturing Associate is responsible for manufacturing bioconjugation products using routine and advanced procedures and documenting all work in production batch records using established good documentation practices. Candidates should demonstrate a strong grasp of biochemistry and bioconjugation concepts and manufacturing methodology, as well as extensive experience with techniques used for protein purification, characterization, and conjugation. The Senior Manufacturing Associate has a solid understanding of advanced laboratory equipment operation and can troubleshoot issues as needed. The Senior Laboratory Associate requires little supervision and can effectively apply biochemical concepts to new products and procedures. (S)he utilizes his/her experience in the investigation of non-conformances, and development and implementation of corrective actions. The Senior Laboratory Associate possesses initiative and experience to suggest and implement procedural and process improvements such as scale-up optimization and new product development to further department and company objectives. (S)he can effectively train and guide all levels of laboratory personnel as needed.
- Prepare for production by reviewing production schedule; study and clarify specifications; calculate job requirements; assemble materials and supplies
- Manufacture custom bioconjugates according to ISO 9001:2015 requirements and established procedures
- Utilize ERP system to assist in production planning, inventory maintenance, and batch release
- Perform column purification/chromatography, biomolecule conjugations, and conjugation kit reagent preparation using manual and automated procedures
- Perform in-process and final QC testing
- Optimize scale-up processes and assist in new product development
- Guide and train junior staff and lead project teams
- Draft and revise manufacturing and ISO related documents as needed
- Utilize specialized technical knowledge and skills to make detailed observations and analyze data to identify issues in processes
- Keep equipment operating by following 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
- BS or BA degree in Chemistry, Biochemistry, Biology, or equivalent discipline
- At least 6 years of relevant manufacturing laboratory experience
- Experience with bioconjugation and protein purification are required
- Strong understanding of ISO 9001:2015 requirements and procedures
- Strong written and verbal skills
- Self-motivated and able to organize and prioritize multiple tasks with minimal supervision
- Able to meet multiple deadlines and work under time constraints
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.