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.
Accountabilities:
- 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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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