Senior Scientist, CMC Analytical

MBX Biosciences•Boston, MA

45d

About The Position

The Senior Scientist, CMC Analytical, will serve as the lead for MBX Reference Standard and Stability programs, ensuring lifecycle management, compliance, and scientific excellence across multiple clinical pipeline molecules. Additionally, this role will provide comprehensive analytical support across Drug Substance (DS), Drug Product (DP), and drug–device combinations, including in-process controls, release, stability, characterization, comparability, clinical in-use studies, and specification setting. Shared responsibilities will also include analytical vendor management, specifically supporting pre-commercial development activities, tech transfer, managing Certificates of Analysis, co-authoring regulatory submissions, and driving quality investigations.

Requirements

Bachelors in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 7+ years of relevant industry experience; or M.S. or PhD with 5+ years of CMC analytical experience in the biopharmaceutical industry.
Strong expertise in analytical method development and validation for peptide small molecules, biologics, or combination products.
Demonstrated experience managing stability and reference standard programs.
Familiarity with regulatory requirements and guidelines (ICH, FDA, EMA, JP) related to CMC analytical development.
Proven ability to interpret complex analytical data and apply scientific judgment to development and troubleshooting.
Experience managing analytical activities at external partners (CROs/CMOs) and driving cross-functional collaborations.
Excellent written and verbal communication skills, including experience authoring regulatory documentation.
Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

Responsibilities

Lead the MBX CMC Analytical reference standard and stability programs, ensuring robust lifecycle management and compliance with internal and regulatory requirements.
Design, implement, and interpret studies supporting reference standard qualification and stability across multiple clinical programs.
Support development, qualification, and validation of analytical methods, ensuring fitness for purpose across clinical and commercial phases.
Collaborate cross-functionally with Quality, Regulatory Affairs, and Clinical teams to align analytical strategies with program milestones.
Provide technical oversight and manage analytical activities at external CROs/CMOs, ensuring data integrity, compliance, and on-time deliverables.
Manage Certificates of Analysis (CoAs) and ensure consistency and accuracy across batches and development phases.
Support specification setting and justification based on statistical analysis, stability data, and regulatory expectations.
Author and review analytical sections of regulatory filings, including IND, INDa, IMPD, and NDA/BLA submissions.
Lead or support investigations for OOT/OOS results, ensuring thorough root-cause analysis, corrective/preventive action (CAPA), and documentation.
Stay current with evolving regulatory guidance, pharmacopeial standards, and best practices in analytical CMC development.
Other responsibilities as assigned.