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Principal Scientist, Upstream Process Development

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 02/06/2019 Job Type: Scientific Job Number: JN -022019-23618
ROLE SUMMARY
  • Successful candidate will provide technical or scientific expertise & leadership in the upstream process development of mammalian cell culture derived recombinant proteins & monoclonal antibodies.
  • In addition to upstream process development candidate will lead efforts for developing & optimizing cell culture processes including process parameter optimization, process characterization & scale-up/tech transfer for large scale product production.
  • Candidate will also have experience with microbial fermentation based processes & associated process development, technical transfer & support successful implementation of production fermentation processes at commercial scale.

PRIMARY RESPONSIBILITIES FOR ROLE
  • Has considerable knowledge in area of protein & monoclonal antibodies production using mammalian host cell systems, experience with microbial based host cell systems for recombinant protein production is a plus.
  • Responsible for design & execution of experiments regarding cell culture media screening/development, evaluate feeding strategies, process parameter optimization & scale-up to support large scale production
  • Candidate will monitor, explore & evaluate next generation technologies to speed up process development.
  • Be responsible for technology transfer to third parties including partners & CMO
  • Supports process technology transfer & scale-up to commercial facilities
  • Individual will be accountable for scientific data review including data integrity verification, statistical analysis & technical report writing.
  • Directly interfaces with other departmental groups (R&D, Quality Assurance, Regulatory Affairs, Supply Chain & Manufacturing)
  • Provide technical leadership to staff with focus on verbal & written communications, teamwork & problem solving
  • Uses scientific knowledge to make decisions on projects.
  • Analyzes data & results and makes recommendations that impact both the science & the business

KNOWLEDGE, SKILLS, & ABILITIES
  • Technical/scientific knowledge of biopharmaceutical processes, both process development & manufacturing scales of operation
  • Knowledge of process scale-up & scale-down methodologies, including process characterization & design of experiments
  • Understanding/experience with wave bag systems & SUBs is essential.
  • Familiarity with Finesse Delta V control systems & PI systems is highly desirable.
  • Experience in process technology transfer within & between organizations, manufacturing support & troubleshooting
  • Writes procedures & technical reports that include data interpretation.
  • Extensive working knowledge of cGMP environments
  • Skilled in application of standardized root cause analysis, investigation tools & methodologies.
  • Proficient with the use of MS Office (Excel, Word, PowerPoint), application software including Unicorn, JMP, Minitab, Design Expert, etc.

QUALIFICATIONS:
  • Minimum of 10 yrs. experience in product development, manufacturing science & technology, process engineering within the pharmaceutical industry required
  • 7 yrs. experience working in a pharmaceutical manufacturing site
  • Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements

EDUCATION:
  • Master s or PhD in science or engineering preferred
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