Position Summary
MBX Biosciences, Inc. is seeking a Director of API Development to oversee all drug substance development for the company’s Precision Endocrine Peptides and will play a key role in driving the portfolio forward from early process development through late stage, including process characterization, validation, and commercialization working with our CDMO partners. The Director of API Development will have a pivotal role in providing strategy and shaping future organizational design, and innovation for the MBX organization.
This position requires a strategic thinker with a deep understanding of peptide drug development, including late-stage and commercialization, exceptional relationship building, technical skills, and the ability to collaborate cross-functionally to ensure efficient and effective development throughout our programs at MBX. This leader will initially manage a small group of vendors with an opportunity for future growth and will report to our Vice President of Product Development.
Key Responsibilities
• Lead drug substance team through preclinical and clinical development to commercialization across MBX’s pipeline of Precision Endocrine Peptides. The role will have end-to-end responsibility of drug substance process development and technical support
• Drive, build, and enhance strategic relationships with CDMO and other partners to advance the drug development pipeline
• Work with CDMOs to drive efficient and cost-effective manufacturing processes
• Provide strategic and operational oversight, and content creation of all regulatory documents and requests for information
• Collaborate with drug product and analytical colleagues to ensure the drug substance physical attributes are understood, controlled, and are appropriate for drug product manufacturing
• Partner cross-functionally throughout the organization including program teams, research, clinical development, new product planning, and regulatory affairs,
• Represent the function internally and externally as needed. Activities include due diligence, regulatory interactions, indication expansion, technology and innovation opportunities, project team, and portfolio review committee
• Develop, own, and execute against the operational budget pertaining to API including manufacturing and process development
• Ensure stage-appropriate data is generated and documented and serve as lead author of drug Substance sections of regulatory filings
• Collaborate effectively with internal and external stakeholders to deliver program objectives
• Other responsibilities as assigned
Experience
• Ph.D. in Chemistry or Chemical Engineering with at least 10 years’ or B.S./ M.S. in Chemistry or Chemical Engineering with at least 15 years’ experience in Drug Substance Development
• Expertise in peptide process development and manufacturing with a track record of scientific innovation and leadership within the pharmaceutical/biopharmaceutical industry
• Strong leadership skills with experience defining the vision for the patient affairs function including strategic planning and supporting the development and growth of team members
• Proven track record of building trusting, meaningful relationships with key stakeholders, cross-functional organizations, and CDMO vendors and partners
• Strong understanding of the legal, regulatory, and compliance environment, including a strong understanding of guidelines and best practices for drug substance development
• Highly collaborative, able to successfully develop and maintain strong working relationships cross-functionally with colleagues and with external stakeholders
• Excellent communication and presentation skills
• Travel: Up to 25%
Company Overview
MBX Biosciences, Inc. is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™, or PEP™, platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.
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 its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the trea
Location: Anywhere
Posted: Sept. 8, 2024, 7:44 a.m.
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