The Pharmaceutical Operations group is seeking a highly motivated scientist/process engineer to join our group. Pharmaceutical Operations is responsible for ensuring that CMC content for NDAs/BLAs is robust and documented, for regulatory filings, and for managing and overseeing Spectrum’s contract manufacturing organizations.
This non-laboratory position is an excellent opportunity for chemical / biopharmaceutical engineers with experience in biologics drug substance process development to apply their broad knowledge to regulatory submissions, control strategy development, and CMC strategy. Candidates with experience in biologics development with an emphasis in process chemistry, process engineering, or process analytical are encouraged to apply.
The position requires building and maintaining strong, open, collaborative relations within Spectrum, and with the contract manufacturing organizations (CMO) we work with. Assists CMOs in trouble-shooting problems in the process and helps solve other production-related problems within set production and safety procedures.
- Work with CMOs to define process and equipment requirements.
- Understand and comply with all elements of the Spectrum quality system as it pertains to duties.
- Have superb understanding of technical and compliance aspects of bioburden control.
- Oversee work of CMOs, on-site at CMO, promoting safe work practices, and generally contributing to the education and training of other group members.
- May serve as Spectrum manufacturing person-in-plant at CMO.
- Must be able to organize information in a comprehensible manner for record keeping or reporting purposes.
- Must be fully competent in arithmetic, algebra and basic statistical analysis.
- Other essential skills: decision making, perception and analysis, comprehension and memorization.
Skills, Education and Experience:
- S./Ph.D. in protein chemistry, chemical engineering, bioengineering, process science or related science and/or 5-10 years in protein chemistry, chemical engineering, bioengineering, process science or related science with 5+ years of pharmaceutical industry experience.
- A good understanding of both upstream and downstream biotech processes and applicable unit operations.
- Knowledge of both coli and mammalian cell culture.
- Demonstrated consistent success in project completion.
- Must be able to communicate in a clear, concise, and diplomatic manner.
- Must be available to work in the evenings and weekends, as required.
Position Location and/or Territory and Travel
- Position is located in Irvine, CA. or Boston MA
- Position will may require up to 50 % travel (or) occasional local travel