Director Formulation Development Jobs in Somerville, MA

Position Summary

The Associate Director, Formulation Development will play a key role on MBX Biosciences' CMC team, supporting the development of peptide therapeutics across our pipeline.

Reporting into our Senior Director, Drug Product- this person will lead formulation design and optimization, oversee studies related to product quality and stability, and support development activities from early assessment through manufacturing transfer. The role requires strong scientific expertise in peptide or protein formulation development, collaboration across cross-functional teams and external partners, and a focus on advancing innovative therapies in a fast-paced biotech environment.

Key Responsibilities

• Lead and contribute to the design, development, and optimization of pharmaceutical formulations for MBX's peptide therapeutics.
• Oversee formulation development laboratory activities to support the advancement of peptide therapeutics across the MBX portfolio
• Support implementation of analytical methods for characterizing peptides, including chromatographic techniques, spectroscopic techniques, and physical characterization in conjunction with AD
• Oversee and ensure the implementation of robust QC procedures and ensure compliance with regulatory guidance and industry standards (e.g., ICH guidelines)
• Plan and conduct non-GMP stability studies as part of formulation development. Contribute to the GMP stability study design to assess the shelf-life and degradation pathways.
• Lead and contribute to the design and execution of drug product process optimization studies, to enhance product performance and manufacturability at scale. Contribute to the process transfer to CDMOs
• Identify and address formulation and analytical technical challenges, e.g., through design experiments, root cause analyses, etc.
• Partner effectively with MBX Regulatory personnel to ensure appropriate data, information, and documentation related to formulation and analytical methods are incorporated into regulatory documents
• Other responsibilities as assigned

Education & Qualifications 

• Bachelor's, M.S 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 formulation and analytical development
• An in-depth understanding of peptide physicochemical stability, particularly for common routes of degradation, and direct experience in optimizing parenteral (liquid and lyophilized) formulations
• Experience with combination products and devices is highly desirable
• Hands-on experience with a variety of analytical methods, including SEC, RP-HPLC, LC-MS, and subvisible particle analysis
• Prior experience in lyophilization formulation, cycle development, and analytical testing
• Familiarity with end-to-end CMC drug development with an understanding of 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 analytical and problem-solving abilities, with a track record of overcoming complex technical challenges in formulation and analytical development
• Strong interpersonal & communication skills (written and oral), with the ability to develop strong collaborative working relationships with stakeholders and across technical functions, both internally and externally, to drive efficient execution of CMC technical development strategies
• Strong organizational skills, ability to multi-task and work in a dynamic, fast-paced environment, with the ability to adapt to changing priorities and deadlines

Travel

You will be expected to travel periodically based on the needs of the business to the extent requested by the Company, including attendance at Together Weeks, Together Days, and functional meetings as requested by the Company.

Company Overview:

MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company's pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism preparing for Phase 3 development; and an obesity portfolio that includes MBX 4291 in Phase 1 development and MBX 5765 in preclinical development, as well as additional discovery candidates. The Company is based in Carmel, Indiana and Burlington, Massachusetts. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.

EEO Statement: 

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.