Principal Scientist – Biologics Process Development
We are seeking a highly motivated, detail oriented and data driven professional with hands-on working experience in mammalian cell culture process development, optimization, scale-up, tech transfer and GMP manufacturing support. The individual will play a critical role in the day-to-day, hands-on management of cell culture process development laboratory work. The incumbent will play a key role in tech transfer cell culture manufacturing process to CMOs and tech support GMP manufacturing. Candidates must be capable of troubleshooting mammalian cell culture related issues and must have a strong background in experimental design and data analysis in an industrial setting.
You will manage a group of scientists and associates and play a critical role in the development, characterization, scale-up and transfer of mammalian cell culture processes from high throughput screening studies to GMP manufacturing support. This important role requires biological and engineering expertise to optimize processes that will ultimately be suitable for GMP production. In addition, the responsibilities will include working both internally and externally collaborators to develop and transfer technologies to meet group objectives.
- Manage a group of scientists and associates and ensure group timelines and deliverables are met.
- Plan, design and execute experiments in defining mammalian cell culture process suitable for large-scale GMP manufacturing.
- Technology transfer cell culture process to CMOs for GMP manufacturing
- Provide technical support for the troubleshooting of development, manufacturing, and scale-up issues as well as the implementation of process changes at CMOs site
- Work closely with internal groups to ensure that corporate objectives are met
- Ensure that data is analyzed and technical reports are completed in a timely fashion
- Ph.D. in a scientific discipline (Chemical Engineering, Biochemical Engineering, Biochemistry, Biology or related field) with 12+ years or MS with 15+ years of relevant experience in the pharmaceutical /biotechnology industries in mammalian cell culture process development, scale-up, tech transfer, and GMP manufacturing support in an industry setting
- Must have experience in managing a group of scientists and associates
- Direct experience with the design, optimization and scale-up of mammalian cell culture processes is a necessity
- Industrial technical transfer experience with mammalian cell culture processes is essential.
- Experience with the design and optimization of mammalian cell culture media and supplements is a plus
- A strong analytical background is highly preferred
- Experience with regulatory filings and documentation is desirable
- 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