Associate Director, Formulation Development

Scorpion Therapeutics; Burlington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director of Formulation Development to lead design, development, and optimization of peptide formulations. You will oversee lab activities and ensure robust QC and regulatory alignment for parenteral products.

Candidate should bring 8+ years in formulation/analytical development, expertise in peptide stability, and experience with SEC/RP-HPLC/LC-MS. Collaboration with Regulatory and CDMOs is essential in a fast-paced environment.

Qualifications

• Advanced degree in a relevant field and 8+ years of industrial experience in formulation/analytical development.
• Strong understanding of peptide stability and parenteral formulation optimization (liquid and lyophilized).
• Experience with end-to-end CMC development and regulatory knowledge (FDA/EMA).

Responsibilities

• Lead design, development, and optimization of peptide formulations and oversee lab activities.
• Oversee formulation development laboratory activities and QC procedures.
• Support analytical method implementation (chromatography, spectroscopy, and physical characterization).
• Contribute to GMP/CMC strategies and regulatory documentation with Regulatory teams.

Skills

Leadership

Communication

Problem-solving

Project management

Education

PhD in pharmaceutical sciences / related field

Tools

SEC

RP-HPLC

LC-MS

Subvisible particle analysis

Job description

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.

Education & Qualifications (Required/Preferred)

• 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.

Travel

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