Senior Process Development Scientist

MBX Biosciences•Boston, MA

22d

About The Position

MBX is seeking a Senior Process Development Scientist to join the Drug Product team and help advance our peptide therapeutic pipeline. Reporting to the Senior Director, Drug Development, this role provides hands‑on technical support across drug product process development, formulation, and manufacturing from early development through clinical and commercial readiness. The Senior Process Development Scientist will lead and support process development activities, engineering runs, and technology transfer, partnering closely with internal CMC, Quality, Regulatory, and Program teams, as well as external CDMOs and CROs. This role is ideal for a motivated scientist who thrives in a fast‑paced, collaborative environment and enjoys solving complex technical challenges to enable successful drug development. The successful candidate will contribute to the design and optimization of robust, scalable drug product processes; oversee engineering activities at CDMOs; support technology transfer and GMP manufacturing; and serve as a subject matter expert across programs. This individual will also play a key role in preparing regulatory‑ready CMC documentation and supporting global regulatory submissions. This is a high‑impact opportunity to shape drug product process strategy, influence development decisions, and help bring innovative peptide therapies to patients.

Requirements

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.
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.

Nice To Haves

Experience with combination products and devices is strongly preferred.
Prior experience in lyophilization cycle development and process characterization preferred.

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.