Location: Bristol, PA
The Bio-Analytical Scientist will be responsible for supporting analytical activities within Antibody Drug Conjugate (ADC) GMP manufacturing and development. This is a hands-on laboratory position with additional supervisory and management responsibilities dependent on experience.
- Develop, validate and execute analytical methods, specifically for biologics including ADCs, required for client projects manufactured to cGMP
- Develop methods for early-phase GMP manufacturing of novel cytotoxic antibody drug conjugate (ADC) compounds Using such techniques as SDS-PAGE, Western Blotting, HPLC, LC-MS, q-TOF, Capillary Electrophoresis, ELISA, peptide mapping, SEC-MALS, DSC, MFI, DLS, cIEF, and CD
- Manage selection, qualification and work carried out by third-party analytical service providers
- Author and review Standard Operating Procedures (SOPs), technical documents, protocols and reports
- Maintain laboratory notebook according to good documentation practices
- Adhere to company’s EHS policies and maintain laboratory and equipment in an orderly fashion
- Adhere to company’s Quality policies and procedures
- Conduct OOS, Non-conformance, and root cause investigations and assist QC Manager with these investigations
- Assisting with trending analysis
- Work with other teams to determine analytical methods needed to support GMP manufacturing
- Engage in activities designed to develop collaborative research with research colleagues and support staff internally and to actively develop appropriate external contacts and networks relevant to the Company’s core business.
- Attend, contribute and if necessary to lead relevant meetings
- Manage their own work schedule effectively and efficiently
- Keep up to date with scientific and technical developments
Education / Experience:
- B.S. or higher degree in biochemistry or related discipline
- 2 – 5 years relevant experience in the biopharmaceutical industry
- Extensive experience in biologics Analytical Development in a GMP environment.