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Upstream Process Development Sr. Scientist II

Oakland-Fremont-Pleasanton Metro Area, California

Post Date: 06/30/2017 Job ID: JN -062017-19442 Industry: Process Dev - Scientific
DUTIES:
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.
SKILLS:
  • 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.
EDUCATION:
  • 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

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