Bioanalytical Scientist - Abzena

Bioanalytical Scientist

Location: Bristol, PA
Area: Chemistry

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.

Main responsibilities:

  • 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

Additional responsibilities:

  • 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.

 

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