Associate Director, CMC, Drug Product

Scorpion Therapeutics; Boston (MA); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Scorpion Therapeutics in Needham, MA, seeks an Associate Director, CMC, Drug Product, to oversee early-stage formulation and manufacturing development of small molecule drug candidates for Phase 1 and 2 programs.

You will lead formulation development, coordinate external CDMOs, author regulatory CMC submissions, ensure cGMP compliance, and collaborate with discovery and development teams, with some international travel.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, or related field.
• 10+ years in pharma/biotech with small molecule drug product development.
• Experience managing external CDMOs and regulatory documentation.

Responsibilities

• Lead formulation development and coordinate clinical trial material manufacturing.
• Manage external CDMOs and ensure timely delivery of cGMP compliant drug product.
• Author regulatory CMC submissions and ensure documentation meets FDA/regulatory requirements.
• Collaborate with discovery and development teams; provide input on stability and packaging.
• Stay informed on industry science, regulatory expectations, and global regulatory submissions.

Skills

Drug product development

CDMO management

Regulatory documentation

Small molecule formulation

Education

PhD in Chemistry, Pharmaceutical Sciences, or related discipline

Job description

Role:

Associate Director, CMC, Drug Product, overseeing early-stage formulation and manufacturing development of small molecule drug candidates for Phase 1 and 2 clinical programs.

Responsibilities:

lead formulation development, manage external CDMOs, coordinate clinical trial material manufacturing, author regulatory CMC submissions, and ensure compliance with cGMP standards. Collaborate with discovery and development teams, provide input on stability and packaging, and stay informed on industry science and regulations.

Qualifications:

PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 10+ years in pharma/biotech; experience in small molecule drug product development, including powders, capsules, tablets, and suspensions; proven CDMO management and regulatory documentation skills.

High-Value:

focus on small molecule drug development, early-phase clinical manufacturing, global regulatory submissions (IND, NDA), cGMP compliance, and cross-functional collaboration.

Work setup:

hybrid in Needham, MA, with potential international travel.