MBX Biosciences, Inc. · 4 hours ago
Senior Process Development Scientist
Greater Boston
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expMBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on novel precision peptide therapies. They are seeking a Senior Process Development Scientist to provide technical support across drug product development, formulation, and manufacturing, while leading process development activities and collaborating with various teams to ensure successful drug development.
BiotechnologyHealth CareTherapeutics
Responsibilities
Contribute to small scale drug product process development on site for MBX’s peptide therapeutics as needed
Support drug product and combination product development and manufacturing activities, including person‑in‑plant oversight
Manage external drug product CDMOs and CROs, ensuring adherence to quality standards, timelines, and budgets
Support process optimization studies, including experimental design and data interpretation, to enhance robustness and scale‑up performance; contribute to process transfer to manufacturing partners
Serve as a drug product SME for CMC and program teams, including participation in technical due diligence, and supporting CDMO/CRO capability assessments, and selection as needed
Provide technical support in troubleshooting and investigations, including root cause analysis and design of experiments to address process or manufacturing challenges
Partner closely with Quality to ensure robust QC procedures are implemented and maintained in compliance with regulatory expectations and industry standards (e.g., ICH guidelines)
Collaborate effectively with Regulatory Affairs to ensure CMC regulatory compliance, including the incorporation of formulation, process descriptions, and qualification/validation data into regulatory submissions
Author, review, and approve technical memos, study protocols, reports, and relevant GMP and quality documentation
Contribute to the authoring and review of drug product–related sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs), and support responses to Health Authority questions
Support the development and integration of drug/device combination products, working cross‑functionally to ensure technical alignment and regulatory compliance
Perform other duties as assigned
Qualification
Required
BS, MS or Ph.D. in pharmaceutical sciences, analytical chemistry, biochemistry, or related field with at least 8 years of relevant industrial experience, with a strong emphasis on process development and drug product manufacturing
Understanding of peptide or protein drug physicochemical characteristics and direct experience in developing/optimizing parenteral, liquid and lyophilized, unit operations
Familiarity with end-to-end CMC drug development including critical milestones and typical bottlenecks
CMC Regulatory knowledge, with a familiarity with regulatory requirements for parenteral drug products (e.g. FDA, EMA)
Highly motivated self-starter who works well both in teams as well as independently
Strong proven problem-solving abilities, with a track record of overcoming complex technical challenges in process development and manufacturing
Excellent interpersonal and communication skills, with the ability to build strong cross‑functional and external partnerships
Strong organizational skills with the ability to multitask in a dynamic, fast‑paced environment and adapt to changing priorities
Demonstrated ability to meet deadlines, deliver results, and maintain high attention to detail and accuracy
Ability to influence, negotiate, and drive alignment across technical and organizational stakeholders
Preferred
Experience with combination products and devices is strongly preferred
Prior experience in lyophilization cycle development and process characterization preferred
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
legacy.thefly.com
2026-01-23
2026-01-22
Company data provided by crunchbase