MBX Biosciences

Associate Director, Formulation Development

Burlington, MA · Director

Sponsorship not specifiedDetected 29 days ago

Process ImprovementGMPFDA RegulatoryExperimental DesignMass SpectrometryAnimal StudiesCommunicationCollaborationProblem SolvingOrganizational Skills

About the role

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 is based in Carmel, Indiana and Burlington, Massachusetts.

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
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
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

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
Strong proven analytical and problem-solving abilities, with a track record of overcoming complex technical challenges in formulation and analytical development
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

To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
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.
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.

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.

This listing is sourced directly from MBX Biosciences's careers page and normalized into a canonical job model.