Principal Scientist: Cell Culture Process Development M-2929 Job in Cambridge 02139, Massachusetts Us
Description
We are seeking a highly innovative and motivated professional with experience in mammalian cell culture process development. The individual will play a key role in the day-to-day, hands-on performance of laboratory work, and must also be capable of troubleshooting cell culture issues. Candidates must have a strong background in mammalian cell culture and recombinant protein expression systems in an industrial setting.
The successful candidate will be involved in the development and characterization of recombinant cell culture processes from bench to pilot scale production. This important role requires biological and engineering expertise to develop and optimize processes that will ultimately be suitable for cGMP production. In addition, the responsibilities will include the transfer and support of these processes to cGMP manufacturing.
Responsibilities:
- Planning and execution of activities within the Cell Culture Process Development team suitable for large-scale cGMP manufacturing including; cell line selection, cell culture process optimization, and process scale-up to pilot scale.
- Assist in technology transfer to cGMP manufacturing by providing technical support, generating development reports, and data analysis. Provide support for the troubleshooting of development, manufacturing, and scale-up issues as well as the implementation of process changes.
- Work closely with internal groups to ensure that corporate objectives are met
- Ensure that technical reports are completed in a timely fashion and serve as author/reviewer as required for regulatory submissions
Qualifications
- Ph.D. in a scientific discipline (Chemical Engineering, Biochemical Engineering, Biology or related field) with 8+ years or MS with 12+ years of relevant experience in the pharmaceutical /biotechnology industries in protein expression and mammalian cell culture development in an industry setting.
- Direct experience with and knowledge of the design, optimization and scale-up of mammalian cell culture processes is a necessity. Experience with mammalian cell culture process development and process transfer for clinical or commercial manufacturing of biopharmaceutical product(s) is required. Process validation and cGMP experience is desirable.
- Extensive hands-on experience with mammalian cell culture development is required. Experience with bioreactor process design, optimization and process scale-up is required.
- Must be highly motivated, 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. Must be able to generate detailed written records of the work accomplished in a timely manner.