Senior Scientist/Principal Scientist - Analytical Development

at Company: Momenta Pharmaceuticals, Inc. in Job Category: Research
posted on 7/22/08 12:00am

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Company
Momenta Pharmaceuticals, Inc.

Contact Name:
Pamela Downey

Email:
pdowney@momentapharma.com

Job Reference Code:
JG

This position will be responsible for the direct development, qualification and validatation, as necessary, of analytical tests for characterization of biopharmaceuticals in a Development organization. The analytical data will be used in support process development and manufacturing efforts as well as for release of GMP (Phase I to Phase III) or GLP samples. This position may also be responsible leading a small group of BS or MS level scientists and technical or project teams focused on the development of products and their corresponding CMC sections for world wide regulatory filings. Due to extensive outsourcing operations, the candidate must be willing to travel (domestic and international).

Strong Analytical Chemistry background with expert level skills in one or more of the following: characterization and analysis of proteins, chromatographic analysis, characterization and analysis of polymeric species, mass spectrometric analysis, method development and validation. Demonstrated experience with all phases of pharmaceutical product development, GMP/GLP testing and method transfer is required.
In addition, the successful candidate will have excellent communication skills including the abiltiy to write method development and validation reports as well as CMC sections of world wide regulatory submissions.

Experience in leading an analytical group focused on pharmaceutical product development with direct experience in the analysis of samples for process development / optimization and for GxP release. Experience with cross funtional teams in a multi-project environment. Direct experience with transfer of analtytical methods as well as with preparation of regulatory filings is required. Experience with characterization of molar mass of polymers and analysis of polymers is an advantage.

Ph.D. or M.S. with appropriate level of experience

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