Tanvex CDMO is Now Bora Biologics
Senior Manufacturing Associate I, Upstream
Tanvex CDMO is Now Bora Biologics, San Diego, California, United States, 92189
Senior Manufacturing Associate I, Upstream
Join the Tanvex CDMO (Now Bora Biologics) as a Senior Manufacturing Associate I, Upstream. This full‑time role supports GMP manufacturing, including cell culture/fermentation and related sub‑processes. The position requires general supervision and involves routine manufacturing activities, executing batch records, and revising SOPs as necessary. Mentoring associates and driving projects are key responsibilities. Flexible shift schedule and overtime may be required.
Responsibilities
Perform moderately complex tasks using defined protocols to achieve project milestones.
Conduct GMP manufacturing activities in assigned upstream areas.
Set up, operate, maintain, and clean upstream bioprocessing equipment, including fermentation skids, centrifuges, homogenizers, inline mixers, filtration skids, and small parts.
Perform basic troubleshooting of bioprocess equipment.
Manually clean and sterilize manufacturing areas, parts, and components.
Participate in regular team meetings to discuss ideas, troubleshoot issues, and suggest project improvements.
Provide mentoring and coaching to colleagues and act as lead when supervisor is unavailable.
Address production issues and report compliance concerns promptly.
Compliance & Documentation
Follow SOPs, cGMPs, plant safety guidelines, and other procedures to produce quality products.
Maintain accurate equipment logs and batch records following Good Documentation Practices.
Draft and revise SOPs and batch records.
Initiate and collaborate on deviations, incident reports, investigations, CAPAs, change controls, technical reports, and validation protocols.
Qualifications
Advanced degree in life sciences or related discipline with 3 years of experience in the pharmaceutical or biotech industry, OR bachelor’s degree with 6 years of experience, OR high‑school diploma/GED with 8 years of experience.
Upstream experience in Cell Banking, Vial Thaw, Seed Expansion, Fermentation/Cell Culture operations, Depth Filtration, Cell Lysis, Inclusion Body Wash, Final Filtration, aseptic sampling, solution preparation, tubing assemblies, and autoclaving.
Knowledge of DeltaV automation software preferred.
Fundamental knowledge of current biologics regulations and cGMP for drug substance operations.
Proficient in Microsoft Word and Excel.
Ability to work with pressurized systems, steam, and corrosive chemicals safely.
Strong documentation skills and detail‑oriented.
Team‑player with effective collaboration and cross‑functional communication skills.
Salary $75,443 – $90,532
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology | Pharmaceutical Manufacturing
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Responsibilities
Perform moderately complex tasks using defined protocols to achieve project milestones.
Conduct GMP manufacturing activities in assigned upstream areas.
Set up, operate, maintain, and clean upstream bioprocessing equipment, including fermentation skids, centrifuges, homogenizers, inline mixers, filtration skids, and small parts.
Perform basic troubleshooting of bioprocess equipment.
Manually clean and sterilize manufacturing areas, parts, and components.
Participate in regular team meetings to discuss ideas, troubleshoot issues, and suggest project improvements.
Provide mentoring and coaching to colleagues and act as lead when supervisor is unavailable.
Address production issues and report compliance concerns promptly.
Compliance & Documentation
Follow SOPs, cGMPs, plant safety guidelines, and other procedures to produce quality products.
Maintain accurate equipment logs and batch records following Good Documentation Practices.
Draft and revise SOPs and batch records.
Initiate and collaborate on deviations, incident reports, investigations, CAPAs, change controls, technical reports, and validation protocols.
Qualifications
Advanced degree in life sciences or related discipline with 3 years of experience in the pharmaceutical or biotech industry, OR bachelor’s degree with 6 years of experience, OR high‑school diploma/GED with 8 years of experience.
Upstream experience in Cell Banking, Vial Thaw, Seed Expansion, Fermentation/Cell Culture operations, Depth Filtration, Cell Lysis, Inclusion Body Wash, Final Filtration, aseptic sampling, solution preparation, tubing assemblies, and autoclaving.
Knowledge of DeltaV automation software preferred.
Fundamental knowledge of current biologics regulations and cGMP for drug substance operations.
Proficient in Microsoft Word and Excel.
Ability to work with pressurized systems, steam, and corrosive chemicals safely.
Strong documentation skills and detail‑oriented.
Team‑player with effective collaboration and cross‑functional communication skills.
Salary $75,443 – $90,532
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology | Pharmaceutical Manufacturing
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