Scientist, Formulations

MBX Biosciences•Burlington, MA

7h•Onsite

About The Position

MBX is seeking a Formulation Development Scientist to join the Drug Product team and help advance our peptide therapeutic pipeline. Reporting to the Associate Director, Formulation Development, this role provides hands on technical support across drug product formulation, process development, and manufacturing from early development through clinical and commercial readiness. The Formulation Development Scientist will collaboratively support formulation development activities in lab as well as partnering closely with internal CMC, Regulatory, Program teams, and 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, optimization, and execution of robust, scalable drug product formulation; review data generated at CDMOs; support technology transfer and GMP manufacturing. 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 strategy, influence development decisions, and help bring innovative peptide therapies to patients.

Requirements

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline with 1+ years, M.S. with 2+ years, B.S. with 4+ years of relevant industry experience.
Understanding of peptide or protein drug physicochemical characteristics.
Strong expertise in chromatographic, mass spectrometric, and electrophoretic techniques (HPLC/UPLC, LC-MS, CE) including method development and qualification for peptide therapeutics or related modalities.
Familiarity with end-to-end CMC drug development including critical milestones and typical bottlenecks.
Adherence to Good Documentation Practices (GDocP) and familiarity with electronic lab notebook (ELN). Strong attention to detail and accuracy in technical documentation.
Some CMC Regulatory knowledge.
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.
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.

Nice To Haves

Prior experience in lyophilization cycle development and process characterization preferred.

Responsibilities

Contribute to small scale drug product formulation and process development on site for MBX’s peptide therapeutics as needed.
Perform a range of routine and non-routine analyses of API and Drug Product for MBX’s peptide portfolio using various pharmaceutical analysis techniques.
Perform hands-on laboratory work including execution of chromatographic, and electrophoretic assays (e.g., RP-HPLC, SEC, IEX, CE-SDS, icIEF).
Support process optimization studies, including experimental design and data interpretation, to enhance robustness and scale‑up performance; contribute to process transfer to manufacturing partners.
Contribute to CMC and program teams, including participation CDMO/CRO study design and data review as needed.
Provide technical support in troubleshooting and investigations, including root cause analysis and design of experiments to address process or manufacturing challenges.
Author 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.