CMC Director - Drug Product
New
Remote, United StatesFull-TimeDirector
Salary215,000 - 225,000 USD per year
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Job Details
Requirements
- Expertise in formulation development, scale-up, and tech transfer for small-molecule oral solid dose (OSD) drug products.
- Experience managing external CDMOs and internal development project teams.
- Proven experience in drug product development strategy from pre-IND through Phase 3.
- In-depth knowledge of global regulatory guidelines and cGMP regulations.
- Technical authority in OSD formulation development and manufacturing.
- Experience leading the preparation and critical review of CMC documents for regulatory submission.
- Ability to work cross-functionally with Regulatory Affairs and Quality Assurance.
- Demonstrated experience in project-level CMC budget management.
- Strong technical writing and documentation review capabilities.
Responsibilities
- Lead the management and oversight of formulation development, scale-up, and tech transfer for small-molecule oral solid dose (OSD) drug product manufacturing.
- Collaborate with external CDMOs and internal development project teams to deliver clinical drug product on established timelines.
- Provide technical and strategic leadership for small-molecule OSD development programs.
- Own drug product development strategy from pre-IND through Phase 3, ensuring phase-appropriate design, control strategy, and documentation.
- Ensure strict adherence to global regulatory guidelines throughout the manufacturing, packaging, and testing processes.
- Serve as the technical authority for OSD formulation development and manufacturing within CMC and the primary point of contact during discussions with health authorities worldwide.
- Review and approve controlled drug product development and manufacturing documentation.
- Lead the preparation and critical review of CMC documents for regulatory submission.
- Work cross-functionally with Regulatory Affairs and Quality Assurance to ensure regulatory compliance and seamless implementation of CMC standards and cGMP regulations.
- Contribute to the development and oversight of project-level CMC budgets, emphasizing cost-effectiveness without compromising quality.
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