Apply on Employer Site

MBX Biosciences, Inc. · 20 hours ago

Senior Scientist, CMC Analytical

Greater Boston

Full-time

Onsite

Senior Level

5+ years exp

MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies. The Senior Scientist, CMC Analytical will lead the Reference Standard and Stability programs, ensuring compliance and scientific excellence across clinical pipeline molecules while providing analytical support for drug substance and product development.

BiotechnologyHealth CareTherapeutics

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

Qualification

Analytical method developmentRegulatory requirements knowledgeStability program managementData interpretationCross-functional collaborationCommunication skillsOrganizational skills

Required

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