Senior Scientist, API Upstream Process Development

Johnson & Johnson - Malvern, PA

Full-time - Senior

Malvern, PA

Chemical Manufacturing

About the position

The Senior Scientist, API Upstream Process Development at Johnson & Johnson will play a crucial role in the therapeutic protein process development group. This position involves leading and executing upstream process development studies, contributing to regulatory filings, and participating in technology development. The successful candidate will work collaboratively in a team environment while also being capable of individual contributions to meet project objectives and timelines.

Responsibilities

• Lead and participate in design of experiments
• Plan and guide study execution
• Lead and participate in control strategy development
• Lead and participate in tech transfer, facility fit, and process scale up/scale down
• Plan and execute process validation studies (laboratory and manufacturing-scale)
• Record and analyze data
• Author and review technical reports
• Lead and participate in scientific investigations and troubleshoot process issues that arise during development, technology transfer, or scale-up
• Contribute to regulatory filings
• Participate in technology development
• Coordinate laboratory training initiatives

Requirements

• Minimum of a Master's Degree in Biological Sciences, Cell Biology, Biochemistry, or Chemical Engineering with a minimum of 6 years of proven experience is required; PhD preferred
• Hands-on experience with laboratory scale cell culture bioreactor equipment and instrumentation is required
• Knowledge of large molecule drug substance (API) upstream manufacturing process development is required
• Highly organized and capable of managing/pursuing multiple projects is required
• Good written and verbal communication skills are required
• Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required
• The ability to report data and present findings to management is required
• Experience with team-based collaborations and direct management of staff is required

Nice-to-haves

• Knowledge of and hands-on experience with cell culture media characterization and/or optimization is preferred
• Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of recombinant proteins is preferred

Benefits

• Comprehensive health insurance
• 401k retirement plan
• Paid time off
• Employee wellness programs
• Professional development opportunities