Senior Scientist, Cell Culture Development and Manufacturing

Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs.

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.

• 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.

• 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.