GMP Bioconjugation Scientist
Location: Bristol, PA
The successful candidate will be responsible for performing scale-up (< 50 g) of Antibody Drug Conjugate (ADC) production processes and cGMP Manufacturing. This is a hands-on laboratory and cGMP manufacturing operations position with additional supervisory and management responsibilities dependent on experience.
- Perform and execute scale-up activities for GMP bioconjugation processes, including familiarization, optimization and trial runs. Bioconjugation processes include but not limited to the areas of ADCs, Fluorescent-Probe Bioconjugation and Protein-Protein cross-linking
- Prioritize work assignments, consistently follow SOPs, Batch Records, ICH and FDA guidelines
- Be responsible for the planning, development and optimization of synthetic routes/strategies, the execution and delivery of bioorganic reactions. This will include the preparation, purification and analytical characterization of all materials.
- Perform laboratory scale experiments in support of GMP bioconjugation projects
- Coordinate activities with QA, QC, Management, and other cross-disciplinary teams
- Maintain clear and detailed records of their work in lab notebooks and batch records
- Author SOPs, batch records and other relevant documents as necessary
- Maintain a safe, pleasant and efficient working environment
- Work with GMP Analytical for outline analytical methods needed to support GMP bioconjugation processes.
- Act as the representative between R&D and the Quality Group for authoring and approving batch records for GMP bioconjugation processes.
Education / Experience:
- B.S. or higher degree in biochemistry, biochemical engineering or related disciplines
- 3-5 years of GMP operations experience
- Experience in scale-up, Process Development and technology transfer of biologics downstream processes, including ultrafiltration/diafiltration and column chromatography methods
- Ability to consistently work with stringent safety habits
- Must be driven and motivated to work in a group or work independently