Related skills
documentation cgmp bioreactor tech transfer pcr📋 Description
- Independently develop and evaluate process changes to optimize upstream AAV yield.
- Manufacture AAV in shake flasks or bioreactors with a team.
- Lead scale-down/up model development for the platform process.
- Author and review technical documentation including batch records, tech transfer protocols, risk assessments.
- Analyze data, draft technical summaries, and present results to cross-functional teams.
- Maintain data integrity with organized lab notebook and data logs.
🎯 Requirements
- BS with 5+ years in Chemical Eng, Biochemistry, Cell & Molecular Biology.
- Hands-on bioreactor experience at small/pilot/large scale.
- Working knowledge of analytical assays (PCR, cell-based assay, gels).
- Broad experience in cGMP biologics manufacturing and documentation; regulatory guidelines preferred.
- Experience drafting study plans, SOPs, batch records, technical reports.
- Highly motivated team player capable of leading by example.
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