Scientist, Analytical Drug Product Development and Technology (DPDT)
Regeneron
Responsibilities:
- Support analytical strategy development for drug products (primary focus on peptides; also antibody–drug conjugates, siRNA, monoclonal antibodies, and bispecific antibodies).
- Develop and qualify analytical methods for critical quality attributes to support formulation development, DP process development, and stability testing (preclinical to clinical).
- Prepare, author, and review analytical technical documents (SOPs, method performance reports, method transfer documents, and inputs to development reports).
- Guide team members in research/development; investigate and solve method-related quality/stability problems; set goals and assign tasks.
- Maintain working knowledge of analytical techniques/instruments; identify and assess novel analytical methods/technologies.
- Evaluate, interpret, and present data at team meetings.
- Collaborate with DPDT and other functional groups to support program development.
- Maintain accurate laboratory records; participate in instrument maintenance and troubleshoot independently.
Qualifications & Required Skills:
- BS in Chemistry, Chemical Engineering, Biochemistry, or related field with ≥7 years research experience, or MS with ≥5 years hands-on research experience.
- Familiarity with peptide/biologic drug product analytical techniques, including capillary/microchip electrophoresis, HPLC/UPLC, and mass spectrometry.
- Ability to independently design experiments and interpret, document, and communicate results.
Preferred Skills:
- Experience with biophysical characterization (e.g., DLS, HIAC) and fluorescent labeling assays.
Application:
- Apply now.