Key Responsibilities:
- Develop analytical methods and purification protocols for extended characterization of therapeutic proteins and gene therapy vectors.
- Conduct biochemical/biophysical characterization to support development, regulatory submissions, and commercialization.
- Apply DOE, advanced statistics, and risk assessments to evaluate and optimize methods and processes.
- Author technical documents (protocols, reports, memos); support regulatory sections and publications; document experiments timely per SOPs.
- Maintain instruments, troubleshoot issues, improve lab/data workflows; follow lab safety procedures.
- Identify and drive process improvement opportunities across Product Biochemistry.
Typical Day:
- Design and execute experiments to enrich, purify, and characterize size/charge variants, complexes, and high-concentration formulations.
- Use internal data and external literature to recommend study designs.
- Document in an electronic lab notebook; present findings; contribute to protocols, method development reports, regulatory sections, and peer-reviewed articles.
- Lead/participate in technology initiatives and continuous improvement; may mentor junior analysts.
- Maintain instruments and order/maintain supplies.
Qualifications/Skills:
- BS/MS/Ph.D. in Biochemistry/Biophysics or related field; 8β10+ yrs (BS/MS) or 0β2 yrs (Ph.D.).
- Protein separation/purification and TFF; mass spectrometry for protein/product identification.
- Recommended: automated FPLC/HPLC (SEC, IEX, affinity), capillary/microchip electrophoresis, SDS-PAGE, western blots, spectroscopy, light scattering.
- Preferred: protein structure/function, mass spectrometry, immunology/immunogenicity; biopharmaceutical industry experience.
- Strong oral/written communication and teamwork; fully onsite.
- Initiative, continuous learning, ability to manage multiple priorities and communicate with stakeholders.