Senior Scientist
King of Prussia , Pennsylvania
April 09, 2017
Basic qualifications:
B.S. or M.S. in Bioprocess/Biochemical Engineering or related Biological Sciences with >5 yrs of industrial experience. Candidate must have hands on experience in the development and transfer of mammalian cell culture processes for the manufacture of protein theraputics.

Candidate must have good understanding of chemically defined cell culture media/feeds impact on recombinant protein productivity. A thorough knowledge of small scale bioreactors and previous hands-on experience with process characterization/process scale-up, transfer and authoring of related reports supporting regulatory submissions is required.

Preferred qualifications:
The candidate must be a highly motivated self-starter, with excellent verbal and written communication skills, and the ability to work effectively in team and matrix environments. The candidate should have demonstrated record of scientific achievement and a broad and integrated knowledge of the cell culture process optimization. Basic knowledge of statistical science/analysis and project management is highly desired. Previous experience with process scale-up/transfer and authoring of CMC sections for regulatory filings is preferred. The candidate will be responsible for writing and reviewing technical documents, technology transfer documents and will participate in authoring of CMC sections for regulatory filings.

The candidate will be responsible for the characterization, and transfer of animal component free cell culture processes into cGMP facilities for early phase projects. The candidate will also evaluate and/or optimize processes for improved facility fit. The candidate will be interfacing with scientists in the maintenance, operation, and harvesting of bioreactors in a small scale development facility. The candidate will interact with scientists/engineers involved in the process scale-up and technology transfer of manufacturing processes for the production of early and late stage clinical supplies. The candidate will represent the department on project teams. In addition, the candidate will be responsible for authoring technical reports, protocols, technology transfer documents, and CMC sections for regulatory filings. The candidate will be expected to interact on a routine basis with colleagues in downstream process development, analytical methods development, clinical manufacturing groups. The candidate will be responsible for evaluating and implementing new technologies in the cell culture area.

The candidate must be highly motivated, have excellent organization and communication skills. The candidate must demonstrate evidence of leadership and teamwork skills. The candidate will also be expected to work independently and in a matrix team environment.

Contact information:

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