We are seeking a Process Development Scientist to lead process development initiatives and drive the advancement of GMP media products. The ideal candidate will have a Master's or Bachelor's degree in a relevant scientific/engineering field with at least 5 years of relevant industry experience.
Requirements
- Act as a technical lead and Subject Matter Expert (SME) in process development of GMP cell culture media products
- Apply Quality by Design (QbD) principles in designing and executing product and process characterization studies, conducting risk assessments, and identifying process controls and specifications
- Lead the technology transfer of manufacturing process to the GMP manufacturing team, ensuring process information and controls are accurately captured in GMP manufacturing batch records and associated documentation
- Support GMP product maintenance and GMP process improvement initiatives by providing technical inputs and conducting studies, as appropriate
- Collaborate across departments with cross-functional teams, presenting technical information, authoring technical reports, and reviewing technical documentation
Benefits
- Comprehensive total rewards package including health benefits, retirement savings, and more
- Competitive salary
- Excellent benefits