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Manager, Upstream Process Development
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Manager, Upstream Process Development : GlaxoSmithKline
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| Job Number |
54420 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
6/16/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Science |
| Required Degree |
PhD |
| Relocation |
Not Required |
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| Description |
Basic Qualification
Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with >8 yrs of industrial experience in developing validation of cell culture based manufacturing processes for the production of bio-pharmaceuticals.
Candidate must have hands on experience developing, characterizing and validation of cell culture processes. The potential candidate will have a very good understanding of CMC requirements for manufacturing processes of biopharmaceuticals. Previous hands-on experience with process scale-up/process characterization and authoring of CMC sections for regulatory filings is a must.
Details
The candidate will lead a team of scientists/engineers responsible for detailed characterization and validation of mammalian cell-culture based manufacturing processes that will support BLA and other regulatory filings. The candidate will provide technical leadership to group of scientists involved in the running of experiments in support of process characterization. The candidate will also interact with scientists/engineers involved in the developing cell culture processes, scale-up and technology transfer of manufacturing processes for the production of Phase 3 clinical supplies and commercial-scale protein production. The candidate will also be responsible for authoring and reviewing technical reports, protocols, technology transfer documents and CMC sections in regulatory filings. The candidate will participate on due diligence teams, in the selection of CMO’s and represent the department on project teams. The candidate will also be expected to interact on a routine basis with colleagues in downstream process development, analytical methods development, clinical and commercial manufacturing as well as regulatory groups. The candidate must be highly motivated, have excellent organization and communication skills. The candidate must have supervisory skills. The candidate will also be expected to work independently and in a matrix team environment. |
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| Requirements |
Preferred Qualification
Hands on experience authoring CMC sections in BLA/MAA’s for biopharmaceuticals. A thorough knowledge of the workings of large scale and small scale bio-reactors, especially aspects concerning mass transfer and mixing times is highly desired. Formal training in Operational Excellence and/or Project Management is highly desired. Advanced knowledge of statistical science/analysis |
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