Position Summary:Bionova is seeking for an experienced Scientists to perform analytical testing to support process development, process characterization studies, and stability studies The Scientist will participate in development, optimization, and qualification of analytical test methods. Bionova is currently in the process of expanding its capabilities as a CDMO through construction of a state-of-the-art GMP manufacturing facility and QC testing laboratory.
Essential Duties and Responsibilities:- Demonstrate scientific leadership with the ability to drive innovation. Lead projects and teams, resolve technical problems. Work both independently and across functional teams.
- Develop, optimize, and verify analytical test methods (focusing on ELISA binding and cell based potency assays, process impurity assays for HCP, residual DNA and residual Protein A etc) for biological products. Experience with UV-vis, HPLC/UPLC, CE, icIEF, binding affinity and, mass spectrometry will be a plus.
- Perform analytical testing to support process development decisions, process characterization studies, and product stability studies.
- Support QC investigation and troubleshooting for GMP lot release and stability testing.
- Prepare and present concise, sound scientific presentations of study results to the internal and external team for decision making.
- Author technical documents such as SOPs for Laboratory and assay procedures, method development reports, method transfer protocols/reports, method qualification protocols/reports, and regulatory filing documents per project needs.
- Troubleshoot equipment and testing to identify root causes of issues. Evaluate new technologies and innovations to improve operational efficiency or expand AS capabilities. Perform general laboratory duties associated with equipment maintenance and good housekeeping.
Working Conditions:- This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
Qualifications:- BS or MS in Pharmaceutical Sciences, Chemistry, Biophysics or Biochemistry and typically 5+ (BS) or 3+ (MS) years of relevant industrial experience.
- Prior 1+ years managerial experience is preferred.
- In-depth understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC,
- Mass Spec, ELISA, microbiological assays, compendial assays, etc)
- Hands-on experience in running, developing, and validating analytical methods
- Creative thinker that can identify better and more efficient methods to address issues and gaps
- Demonstrate ability to work independently and on cross-functional teams
- Strong attention to detail
- Effective verbal and written communication skills
