Senior Scientist, Cell Culture Development and Manufacturing

Momenta Pharmaceuticals

(Cambridge, Massachusetts)
Full Time Travel Required
Job Posting Details
About Momenta Pharmaceuticals
Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs.
Summary
We are seeking a highly motivated, well organized, and detail oriented professional with experience in mammalian cell culture process development and hands-on working experience in tech transfer and GMP manufacturing support.
Responsibilities
* Lead effort in technology transfer of cell culture manufacturing processes to CMO facilities. * Work collaboratively with CMOs in transferring and scaling-up cell culture manufacturing process and reviewing manufacturing batch records. * As the person in plant, provide technical support for the troubleshooting of cell culture manufacturing and scale-up issues as well as the implementation of process changes. Tracking the progress of tech transfer and GMP manufacturing. Assist in closing deviations. * Perform statistical data analysis and trending * Ensure tech reports are completed in a timely fashion.
Ideal Candidate
* Hands-on working experience in tech transfer of cell culture manufacturing process and on-site GMP manufacturing support is required. * Direct experience with statistical data analysis and trending is a necessity. * Experience in the design, optimization and scale-up of mammalian cell culture processes is a plus. * Experience with regulatory filings and documentation is desirable. * Must be able to travel internationally. * Must have excellent organizational and communication skills. Must be able to work independently and as part of a multi-disciplinary team and committed to high quality work. * Ph.D. in a scientific discipline (Chemical Engineering, Biochemical Engineering, Biology or related field) with 5-8 years or MS with 8+ years of relevant experience in the pharmaceutical /biotechnology industries in technology transfer, process scale-up and GMP manufacturing support.

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