Bioassay Scientist

MBX Biosciences • Burlington, MA

10d

About The Position

The Scientist, Analytical Development – Bioassay will support the development, qualification, transfer, and lifecycle management of potency assays for peptide therapeutic programs from early clinical to commercial development. This role will focus on the design and execution of cell-based and/or binding bioassays to enable product characterization, release, stability testing, and comparability assessments. The Scientist will work collaboratively with other MBX functions and external CDMO partners to ensure phase-appropriate, scientifically sound, and compliant bioassay strategies are implemented across the portfolio.

Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline with 1+ years, M.S. with 3+ years, 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 (eg. 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 Haves

• Experience managing analytical activities at external partners (CROs/CMOs) and driving cross-functional collaborations preferred.

Responsibilities

• Lead development, qualification, and validation of bioassays for release and characterization testing of therapeutic peptide products, ensuring fitness for purpose across clinical and commercial phases both internally and at external vendors.
• Build and maintain bioassay analytical capabilities at internal lab, 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.
• Other responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree