Director Pharmaceutical Operations-Biologics

Company: Spectum Pharmaceuticals Inc.
Location: Irvine
Posted on: February 16, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

• Work with CMOs to define process and equipment requirements.
• Understand and comply with all elements of the company 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 company 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.
  • 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.

Keywords: Spectum Pharmaceuticals Inc., Irvine , Director Pharmaceutical Operations-Biologics, Executive , Irvine, California