CMC Director - Drug Product

TL;DR

CMC Director - Drug Product (CMC/Small Molecule OSD): Lead end-to-end drug product development strategy for small-molecule oral solid dosage forms, from pre-IND through late-stage clinical development, with an accent on formulation design, scalable manufacturing/tech transfer, and regulatory-ready CMC documentation. Focus on solving complex cGMP and global regulatory compliance challenges while guiding cross-functional CMC teams and external CDMO partners.

Location: Based in the United States

Salary: $215,000–$225,000 per year

Company

hirify.global lists this role on behalf of a partner company.

What you will do

• Lead formulation development, scale-up, and tech transfer for small-molecule oral solid dose (OSD) drug products with internal teams and external CDMOs.
• Own end-to-end drug product development strategy from pre-IND through Phase 3, including phase-appropriate formulation, control strategy, and documentation.
• Serve as primary CMC subject matter expert for OSD development programs and provide technical leadership for cross-functional CMC teams.
• Oversee manufacturing, packaging, and testing to ensure compliance with global regulatory requirements and cGMP standards.
• Lead preparation and critical review of CMC sections for regulatory submissions (e.g., CTD modules) and support regulatory interactions with global health authorities.
• Collaborate with Regulatory Affairs and Quality Assurance to execute CMC strategies and contribute to CMC budgeting and resource planning.

Requirements

• Advanced degree (PhD or equivalent experience) in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related field.
• Extensive CMC drug product development experience for small-molecule oral solid dosage forms.
• Proven track record leading formulation development, scale-up, and tech transfer in a pharmaceutical/biotech environment.
• Deep knowledge of global regulatory requirements and late-stage clinical development pathways (IND, NDA, and related CMC expectations).
• Strong experience partnering with CDMOs and managing external manufacturing partnerships.
• Strong cGMP/quality systems knowledge and experience preparing/reviewing regulatory submission documentation (CTD modules or equivalent).

Culture & Benefits

• Comprehensive medical, dental, and vision coverage (90% employer-paid).
• 401(k) retirement plan with company match.
• Flexible paid time off policy.
• Adoption assistance program.
• Opportunity to contribute to cutting-edge drug discovery and development programs in a science-driven, collaborative environment.
• Commitment to diversity, inclusion, and scientific excellence.

Hiring process

• AI-powered matching reviews applications quickly and objectively against core requirements.
• Shortlist is shared with the hiring company; interviews and assessments are managed by the internal team.