CMC Director - Drug Product
New
United StatesFull-TimeDirector
Salary215,000 - 225,000 USD per year
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Job Details
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.
Responsibilities
- 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.
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