Your Role: Research Scientist - Product Development
Responsibilities:
- Develop and execute analytical strategies for biopharmaceutical products from development to commercialization.
- Perform protein characterization and structural elucidation using techniques like LC-MS/MS, CE-SDS, HPLC, and cIEF-MS.
- Lead the development, validation, and transfer of analytical methods to QC/GMS labs.
- Author technical reports, protocols, and relevant sections for regulatory submissions.
- Collaborate with cross-functional teams, including process development and formulation, to advance the pipeline.
What You Need to Succeed (minimum qualifications):
- PhD in Analytical Chemistry, Biochemistry, or a related scientific discipline.
- Demonstrated experience in HPLC/CE separations and mass spectrometry of biomolecules.
- Hands-on experience with protein characterization techniques such as LC-MS/MS, CE-SDS, Peptide Mapping, and Intact/Subunit Mass analysis.
What will give you a competitive edge (preferred qualifications):
- Experience in a GLP/GMP environment and familiarity with regulatory guidelines (e.g., ICH, FDA).
- Proven ability to troubleshoot complex analytical instrumentation and assays.
- Experience serving as an analytical lead on project teams.
Benefits and Perks:
- Multiple relocation packages; two weeklong shutdowns in the US (in addition to PTO); 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401K matching.
Additional Information:
- Travel: 10% or less; Location: Global HQ - Indianapolis, IN (On-Site).