Upstream Process Development Sr. Scientist II
Oakland-Fremont-Pleasanton Metro Area, California
The incumbent will provide technical or scientific expertise and leadership in the upstream process development of mammalian cell culture derived recombinant proteins and monoclonal antibodies.
- Responsible for developing cell culture medium, feeding strategies, process parameter optimization, and scale-up to support large scale production of material for preclinical and clinical activities.
- Proficient in writing development reports, protocols, batch records and technology transfer reports.
- Applies scientific and engineering expertise to develop recombinant protein production processes suitable for large-scale cGMP manufacturing.
- Responsible for independently identifying actions required to support departmental objectives.
- Execute action plans independently, as part of a team, or as the lead for a departmental team.
- Responsible for representing the functional area or capable of leading a cross-functional team to achieve identified objectives.
- Independently prepares and critically edits procedures or technical reports of a complex nature, assimilating information across functional areas, suitable for inclusion in IND, BLA, or equivalent regulatory submission.
- Develops creative, novel programs to meet departmental objectives.
- Leads others in problem-solving efforts.
- Advanced ability to creatively apply scientific principles in problem solving in potentially novel areas.
- Mentors/trains staff in relevant principles and/or guidelines.
- Responsible for serving as technical consultant within functional area or site.
- Independently designs, executes, and interprets results for novel and scientifically complex study programs.
- Mentors others in experimental design.
- Responsible for directing others in study execution.
- Maintains laboratory facilities in accordance with company policies and industrial best practices.
- Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
- Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.
- MUST have industry experience working with mammalian cells in upstream process development.
- Prior GMP experience is REQUIRED
- Must demonstrate strong scientific/technical and interpersonal skills & the ability to communicate effectively.
- A good working knowledge of quality design approaches and process analytical tools to drive process understanding and develop robust processes is highly desirable.
- Capable of leading a cross-functional team to achieve identified objectives.
- Ability to independently prepare & critically edit complex procedures or technical reports.
- Must have excellent problem solving skills.
- Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology)
- PhD + 5years, or MS with 8+ years .
- BS + 10-11 years