Associate Director, Formulation Development
On-site · Indianapolis, Indiana, United States or Burlington, Massachusetts, United States
Job Summary
Lead the design, development, and optimization of pharmaceutical formulations for MBX’s peptide therapeutics; oversee formulation development laboratory activities; implement analytical methods for peptide characterization; ensure robust QC procedures and regulatory compliance (ICH/guidance); plan non-GMP and GMP stability studies; drive drug product process optimization and tech transfer to CDMOs; identify and address formulation and analytical challenges; partner with Regulatory to integrate data into regulatory documents; collaborate across cross-functional teams and external partners; travel as required to advance development programs; role requires strong peptide/protein formulation expertise and ability to operate in a fast-paced biotech environment.
Required Qualifications
- Bachelor's, MS or Ph.D. in pharmaceutical sciences, analytical chemistry, biochemistry, or related field with at least 8 years of relevant industrial experience
- strong emphasis on formulation and analytical development
- hands-on experience with SEC, RP-HPLC, LC-MS, and subvisible particle analysis
- experience with lyophilization formulation, cycle development, and analytical testing
- familiarity with end-to-end CMC drug development and regulatory requirements for parenteral products
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.