CMC Director - Drug Product

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CMC Director – Drug Product based in United States.

This role is a senior technical leadership position responsible for driving end-to-end drug product development strategy across small-molecule oral solid dosage forms. You will play a critical role in advancing programs from pre-IND through late-stage clinical development, ensuring robust formulation design, scalable manufacturing processes, and regulatory compliance. Acting as a key technical authority, you will guide cross-functional teams and external manufacturing partners to deliver high-quality clinical and commercial drug products. The position requires deep expertise in formulation development, tech transfer, and CMC strategy within a highly regulated global environment. You will collaborate closely with regulatory, quality, and external CDMO partners to ensure alignment with global standards. This is a high-impact role where scientific rigor, strategic oversight, and operational execution converge to directly support the advancement of life-changing therapies.

• Lead formulation development, scale-up, and tech transfer activities for small-molecule oral solid dose (OSD) drug products in collaboration with internal teams and external CDMOs.
• Define and own end-to-end drug product development strategy from pre-IND through Phase 3, ensuring phase-appropriate formulation, control strategy, and documentation.
• Provide technical leadership for OSD development programs, serving as the primary subject matter expert within CMC functions.
• Oversee manufacturing, packaging, and testing processes to ensure compliance with global regulatory requirements and cGMP standards.
• Act as the technical authority for drug product development and the key liaison with global health authorities during regulatory interactions.
• Review, approve, and ensure quality of controlled manufacturing and development documentation.
• Lead preparation and critical review of CMC sections for regulatory submissions and filings.
• Collaborate closely with Regulatory Affairs and Quality Assurance to ensure seamless compliance and execution of CMC strategies.
• Contribute to CMC budgeting and resource planning with a focus on cost efficiency and quality excellence.

Requirements:

• Advanced degree (PhD or equivalent experience preferred) in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related field.
• Extensive experience in CMC drug product development, with strong expertise in small-molecule oral solid dosage forms.
• Proven track record leading formulation development, scale-up, and tech transfer in a pharmaceutical or biotech environment.
• Deep understanding of global regulatory requirements, including IND, NDA, and late-stage clinical development pathways.
• Strong experience collaborating with CDMOs and managing external manufacturing partnerships.
• Demonstrated ability to lead cross-functional CMC teams and serve as a technical authority in regulatory discussions.
• Strong knowledge of cGMP, quality systems, and pharmaceutical manufacturing processes.
• Experience preparing and reviewing regulatory submission documentation (CTD modules or equivalent).
• Strong strategic thinking and ability to balance technical depth with program-level decision-making.
• Excellent communication and leadership skills, with the ability to influence internal and external stakeholders.

Benefits:

• Competitive annual salary range of $215,000 – $225,000.
• 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.
• Highly innovative, science-driven, and collaborative work environment.
• Strong commitment to diversity, inclusion, and scientific excellence.