cgmp jobs in San Diego

Associate Director of Technical Operations at a biopharmaceutical company overseeing CMC (Chemistry, Manufacturing, and Controls) strategy for a diverse portfolio of small-molecule drugs in development through commercialization. Leads external manufacturing partners (CMOs), manages technology transfer and scale-up activities, ensures cGMP compliance, and authors regulatory submissions.…See more Requires 8+ years of progressive CMC and drug development experience with demonstrated leadership across multiple CMC disciplines and small-molecule, peptide, and biologic manufacturing.

The QA Associate II supports quality assurance operations in a regulated manufacturing environment, ensuring materials, processes, and products comply with cGMP and company procedures. Responsibilities include reviewing batch records and analytical data, assessing deviation and CAPA closure, conducting GMP documentation reviews and line clearance inspections, and supporting material/equipment qualification and audit activities.…See more The role requires independent judgment on routine quality decisions, cross-functional collaboration with Manufacturing, QC, and other departments, and the ability to draft and revise SOPs and quality documentation. A Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment are required; cell therapy, aseptic technique, and cleanroom experience are valued.

The QA Associate II reviews manufacturing batch records, analytical test results, and quality documentation to ensure compliance with cGMP and company procedures. Responsibilities include assessing deviations and CAPAs, conducting line clearance inspections and process observations, supporting material and equipment qualification, and participating in audits and investigations.…See more The role requires judgment in routine and moderately complex quality decisions, cross-functional collaboration, and SOP documentation in a regulated biopharmaceutical manufacturing environment.

QA Associate II supports manufacturing operations at a cell-therapy biotech company, reviewing batch records, analytical results, and quality documentation to ensure compliance with cGMP and company procedures. The role involves assessing deviations and CAPAs, conducting line clearance inspections, performing GMP documentation reviews, and supporting material/equipment qualification and audit activities.…See more The person will exercise judgment on routine and moderately complex quality issues, escalate concerns appropriately, and collaborate cross-functionally with Manufacturing, QC, and Facilities. The position requires a Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment.

As a Full Stack Engineer at Nucleus Biologics, you will develop and maintain software tools for scientists and manufacturing teams. Responsibilities include EC2 and RDS administration, Docker container lifecycle management, PostgreSQL database maintenance, monitoring ERP/QMS sync jobs, and resolving customer and internal issues.…See more You'll need strong Python (FastAPI/Django/Flask), React/TypeScript, PostgreSQL, and practical DevOps skills with AWS (EC2, RDS, S3), Linux, Docker, and Nginx.

This Quality Assurance Specialist II role supports clinical trial projects at a pharmaceutical CDMO, ensuring compliance with cGMP and SOPs throughout the product lifecycle. Responsibilities include pre- and post-execution batch record review, authoring/updating QA and compliance documentation, participating in investigations and deviation writing, and reviewing change controls.…See more The candidate must demonstrate strong knowledge of GMP environments, proficiency with MS Office (especially Excel) and ERP systems like JD Edwards, and 5–10+ years of relevant pharmaceutical QA experience depending on education level.