My client; a Top 10 Biotech company in the South San Francisco area is currently looking for a highly collaborative Process Development Scientist to lead Cell Culture Process Development from cloning stage in preclinical programs through the late stage process characterization to prepare for commercialization. The candidate will use novel and innovative techniques to improve production quality while working with adjacent groups within the company as well as Contract Manufacturing Organizations.
Responsibilities:
- Create and examine experiments covering clone screening, process development, process characterization and troubleshooting.
- Experiments will be created for fed-batch, stirred-tank bioreactors (AMBR15, 2-20L glass vessels, 50L SUB)
- Create and guide with respect to technical development reports
- Help of GMP mfg; will include BPR review and PIP duties
- Actively involved in CMC teams to drive progress
- Guide and mentor junior PD associates
Education/Experience:
- For Scientist I: PhD in the Life Sciences with 0-3 years of Biopharma industry experience OR an MS/BS in the Life Sciences and 5 yrs experience
- For Scientist II: PhD in the Life Sciences with 3+ years of Biopharma industry experience
Professional Requirements:
- Cell culture process development setting, including operation of stirred-tank bioreactors and associated instruments are strongly preferred.
- Troubleshooting and data analysis skills are highly desired.
- Bioengineering concepts (e.g. PID control, kLa, scaleup/scaledown etc.)
- Using and programming SCADA software (BioXpert, Lucullus, MFCS etc.).
- Automation or microbioreactor systems (esp Ambr15) is preferred.
- DoE and/or statistical programming (R, JMP, etc).
- Technical writing skills and familiarity with formalized SOP systems, QA systems, and GMP batch records (either directly or via process transfer)
- Cancer biology, immunology, and/or protease biology would be beneficial.
- FACS analysis and/or developing plate-based assays would be a plus
