Descripción
You provide global process engineering expertise for large molecule drug substance manufacturing, connecting technical know-how with manufacturing sites worldwide.
Tasks
- Support process industrialization and coordinate process gap assessments
- Integrate identified risks into the risk log and develop mitigation strategies
- Drive systematic process and technical product health improvements
- Execute validated state support activities and respond to evolving compliance needs
- Provide technical expertise for engineering runs and second-level troubleshooting support
- Lead non-product specific root cause analyses and investigations
- Support process-related projects including validation studies and process transfer
Profile
- B.S. or M.S. in Chemical, Biochemical Engineering, or related discipline
- 7+ years of industrial experience in process development, process engineering, or manufacturing operations
- Experience in process engineering, validation, or technology transfer (E. coli & CHO processes)
- Deep expertise in E. coli systems strongly preferred
- Familiarity with pharmaceutical quality systems and regulatory requirements
- Advanced verbal and written communication skills
- Willingness to travel less than 10 percent
Offer
- 80-100% workload
- 3-6 months interim, then a permanent position
Company
Pharmaceutical manufacturing