Scientist, Analytical Development

MBX Biosciences • Burlington, MA

11h • Onsite

About The Position

The Scientist, Analytical Development will support the development, qualification, transfer, and lifecycle management of physicochemical and impurity analytical methods for peptide therapeutic programs from early clinical to commercial development. This role will focus on the design and execution of chromatographic and electrophoretic methods (LC, LC-MS, and CE) to enable product characterization, release, stability testing, and comparability assessments. Reporting into our Associate Director of Analytical Development, this individual will work collaboratively with other MBX functions and external CDMO partners to ensure phase-appropriate, scientifically sound, and compliant physicochemical and impurity methods are implemented across the portfolio.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline with 1+ years, M.S. with 2+ years, B.S. with 4+ years of relevant industry experience.
• Strong expertise in chromatographic, mass spectrometric, and electrophoretic techniques (HPLC/UPLC, LC-MS, CE) including method development and qualification for peptide therapeutics or related modalities.
• Familiarity with regulatory requirements and guidelines (ICH, FDA, EMA, JP) related to analytical method development, validation, and control strategies.
• Proven ability to interpret complex analytical data (e.g., chromatographic profiles, spectral data) and apply scientific judgment to development and troubleshooting.
• Excellent written and verbal communication skills, including experience authoring method development and qualification documentation.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

Nice To Haves

• Hands-on experience with mass spectrometry for peptide characterization (e.g., intact mass, peptide mapping, impurity identification) preferred.
• Experience supporting analytical activities at external partners (CROs/CMOs) and operating in cross-functional collaborations preferred.

Responsibilities

• Perform a range of routine and non-routine analyses of API and Drug Product for MBX’s peptide portfolio using various pharmaceutical analysis techniques.
• Perform hands-on laboratory work including method development, optimization, troubleshooting, and routine execution of chromatographic, mass spectrometry, and electrophoretic assays (e.g., RP-HPLC, SEC, IEX, CE-SDS, icIEF, LC-MS).
• Help build and maintain internal analytical capabilities for LC/MS/CE platforms, including instrument qualification, maintenance, and training of other staff.
• Provide technical support for analytical development activities at external CROs/CMOs.
• Collaborate cross-functionally with Discovery, Pre-Clinical, Quality, and Regulatory teams to ensure analytical support priorities are aligned with program needs.
• Co-author and review analytical method development, validation, and characterization sections of regulatory filings, including IND, INDa, IMPD, and NDA/BLA submissions.
• Support investigations for OOT/OOS analytical results.
• Stay current with evolving regulatory guidance, pharmacopeial standards, and best practices in chromatographic and mass spectrometry-based 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
• Number of Employees: 1-10 employees