Our client is seeking a Senior Scientist Upstream Process Development in Seattle, WA!
Our client is a biotech company primarily focused on bringing novel oncology and hematology therapeutics to the market. They are leveraging an innovative platform technology to cancer immunotherapy to ultimately improve outcomes for cancer patients. Offering breakthrough treatment options, our client attracts some of the most innovative minds in the field.
Specific Responsibilities:
The Senior Scientist is a hands-on position and plays an integral role in planning, design of experiments, and the daily execution of the Upstream Process Development function. The primary role will be to develop and transfer robust scalable mammalian cell culture processes to clinical manufacturers to produce bispecific protein therapeutics for clinical trials (70% laboratory and 30% office setting). The ideal candidate would have experience with operating bioreactors, CHO cell biology, protein expression and filing regulatory submissions such as IND/IMPDs.
- Operation of bioreactors (inoculation, monitoring, and harvesting experimental or production bioreactor cell-cultures).
- Detailed planning of experiments in collaboration within the Process Development group and other groups. Participation in the planning of project timelines, deliverables, and milestones.
- Authoring and reviewing SOPs, batch records, production protocols, deviation assessments, technical reports for GMPs and CMC sections of regulatory filings.
- Prepare cell-culture media and other cell-culture solutions appropriate to scale.
- Frequent weekend work (usually ~2 hours at a time).
- Occasional travel, usually domestic.
Qualifications:
- Minimum Education/Experience in Chemical or Biochemical Engineering, Biochemistry, or related field:
- Ph.D. and 2+ years relevant industry experience
- MS/MA and 10+ years relevant industry experience
- BS/BA and 12+ years relevant industry experience
- Experience with developing cell-culture processes and the industrial scale-up of mammalian manufacturing cultures for clinical production of monoclonal antibodies or recombinant therapeutic proteins.
- Ability to operate bioreactors of various types and sizes, filtration systems, cell counters and other instruments.
- Ability to troubleshoot Upstream issues using knowledge, skills, precedents, and practices.
- Experience in design of experiments (DoE), analysis of results, authorship of technical reports and presentations for both internal and external uses.
- Knowledge of cGMPs and regulatory requirements for therapeutic biologics.
- Excellent organization and communication skills.
Qualified Candidates, Please Send us your CV
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