Associate Director, Formulation Development

Associate Director, Formulation Development Key Responsibilities

• Lead and contribute to the design, development, and optimization of pharmaceutical formulations for peptide therapeutics.
• Oversee formulation development laboratory activities.
• Support implementation of analytical methods for characterizing peptides, including chromatographic, spectroscopic, and physical characterization.
• Oversee and ensure robust QC procedures and compliance with regulatory guidance and industry standards (e.g., ICH guidelines).
• Plan and conduct non-GMP stability studies; contribute to GMP stability study design to assess shelf-life and degradation pathways.
• Lead and contribute to drug product process optimization studies to enhance performance and manufacturability at scale; contribute to process transfer to CDMOs.
• Identify and address formulation and analytical technical challenges (e.g., design experiments, root cause analyses).
• Partner with Regulatory personnel to incorporate formulation/analytical data into regulatory documents.

• BS/MS/PhD in pharmaceutical sciences, analytical chemistry, biochemistry, or related field; 8+ years relevant industrial experience emphasizing formulation and analytical development.
• In-depth understanding of peptide physicochemical stability and experience optimizing parenteral (liquid and lyophilized) formulations.
• Combination products/devices experience highly desirable.
• Hands-on analytical methods experience (SEC, RP-HPLC, LC-MS, subvisible particle analysis).
• Experience in lyophilization formulation, cycle development, and analytical testing.
• Familiarity with end-to-end CMC drug development, critical milestones, and bottlenecks.
• CMC regulatory knowledge for parenteral drugs (e.g., FDA, EMA).
• Strong self-starter, analytical/problem-solving skills, communication, and organizational/multitasking ability in a fast-paced environment.

• Periodic travel as needed by the business, including attendance at Together Weeks, Together Days, and functional meetings.