MBX Biosciences is hiring a Bioassay Scientist to join the Analytical Development team. In this role, you will support the development, qualification, transfer, and lifecycle management of potency assays for peptide therapeutic programs from early clinical to commercial development.
What You'll Do
- Lead development, qualification, and validation of bioassays for release and characterization testing of therapeutic peptide products.
- Build and maintain bioassay analytical capabilities at the internal lab, and train and mentor junior technicians internally and at external partners.
- Provide technical oversight and manage bioassay development activities at external CROs/CMOs, ensuring data integrity, compliance, and on-time deliverables.
- Collaborate cross-functionally with Discovery, Pre-Clinical, Quality, and Regulatory teams to ensure potency strategy is aligned with program needs.
- Author and review biological characterization and testing sections of regulatory filings, including IND, INDa, IMPD, and NDA/BLA submissions.
- Lead or support investigations for OOT/OOS bioassay results.
- Stay current with evolving regulatory guidance, pharmacopeial standards, and best practices in potency assay analytical development.
What We're Looking For
- A Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline with 1+ years, an M.S. with 3+ years, or a B.S. with 5+ years of relevant industry experience.
- Strong expertise in bioassay methods (ELISA, ligand-binding assays, reporter assays, or other potency platforms) including method development and GxP qualification or validation for either peptide small molecules or protein biologics.
- Familiarity with regulatory requirements and guidelines (ICH, FDA, EMA, JP) related to cell-based potency assay development and validation.
- Proven ability to interpret complex analytical data (e.g., dose-response modeling, parallel line analysis, 4PL/5PL curve fitting) and apply scientific judgment to development and troubleshooting.
- Excellent written and verbal communication skills, including experience authoring GxP method development and qualification documentation.
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
Nice to Have
- Experience managing analytical activities at external partners (CROs/CMOs) and driving cross-functional collaborations.
Technical Stack
- ELISA
- Ligand-binding assays
- Reporter assays
- Potency platforms
Work Mode
This is an onsite position based in Carmel, Indiana.
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination.
