MBX Biosciences, Inc. · 2 hours ago
Senior Scientist, Drug Substance
Greater Boston
Full-time
Onsite
Senior Level
5+ years expMBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies. The Senior Scientist, Drug Substance will drive the development and optimization of synthetic routes for peptide drug substances, providing technical leadership and oversight for external CDMOs while collaborating across various teams.
BiotechnologyHealth CareTherapeutics
Responsibilities
Design, develop, and optimize robust, cost-effective synthetic routes to drug substance, drug substance intermediates, and starting materials, with a focus on step reduction, convergence, scalability, efficiency and sustainability
Contribute to the development and execution of control strategies in alignment with global regulatory expectations
Support the qualification, technical oversight, and ongoing management of CDMOs manufacturing and releasing MBX’s peptide drug substance projects
Lead and support manufacturing campaigns for products at external CDMOs
Participate in technical transfers, process troubleshooting, and manufacturing investigations at partner sites
Contribute to Quality-by-Design (QbD) activities for late-stage development, including risk assessments, identification of critical quality attributes (CQAs), and establishment of control strategies
Support process engineering, scale-up, and process safety studies in collaboration with internal and external experts
Assist with analytical method development, qualification, and validation strategies as they relate to stage-appropriate drug substance development and manufacturing
Author and/or technically review in-process and release specifications, analytical methods, stability protocols, and master batch records
Contributes to the preparation and technical review of CMC sections of regulatory submissions for US and ex-US filings
Ensure activities are aligned with relevant regulatory guidance (e.g., ICH Q7, ICH Q11)
Work closely with internal stakeholders, including Discovery, Analytical Chemistry, Quality, Regulatory CMC, and Clinical teams
Collaborate effectively with external consultants and manufacturing partners to ensure alignment of technical and program objectives
Other responsibilities as assigned
Qualification
Required
Bachelors in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 7+ years of relevant industry experience; or M.S. or PhD with 5+ years of CMC drug substance experience in the biopharmaceutical industry
Strong expertise in peptide drug substance development and manufacturing for clinical scale supply, process characterization and optimization, technical transfers, and process validation
Solid knowledge of cGMPs, Quality systems, and global regulatory requirements
Experience with drafting of regulatory submissions (IND, NDA, MAA, etc.)
Familiarity with regulatory requirements and guidelines (ICH, FDA, EMA, JP) related to CMC development
Proven ability to interpret complex analytical data and apply scientific judgment to development and troubleshooting
Experience managing 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
Preferred
Experience with an asset that was successfully commercialized is a plus
Company
MBX Biosciences, Inc.
MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs™).
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$238.4MKey Investors
Deep Track CapitalWellington ManagementFrazier Healthcare Partners
2024-09-13IPO
2024-08-05Series C· $63.5M
2022-11-14Series B· $115M
Leadership Team
P. Kent Hawryluk
President & CEO
Michelle Graham
Chief Human Resources Officer
Recent News
Longevity.Technology
2026-01-25
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2026-01-23
2026-01-22
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