Director CMC
Job Title: Director, CMC
Location: Remote
Company Overview:
Our client is an early-stage biotechnology company dedicated to translating innovative therapies from academic and internal labs through human clinical trials. They are committed to advancing science and improving patient outcomes through cutting-edge research and development.
Position Summary:
Our client is seeking a Director, CMC to manage oversight of the CMC program across all phases of Preclinical and Clinical Development. The primary responsibilities will include:
- Working closely with CDMOs and Consultants to ensure timely and high-quality delivery of Drug Substance and Drug Product.
- Managing supply distribution for clinical studies.
- Participating in regulatory submissions.
Key Responsibilities:
- Oversee the CMC program from preclinical through clinical development phases.
- Collaborate with CDMOs and consultants to ensure the delivery of high-quality Drug Substance and Drug Product.
- Manage supply distribution for clinical trials.
- Contribute to regulatory submissions and ensure compliance with relevant guidelines.
Qualifications:
- Advanced degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences) with 8-10 years of industry experience.
- Extensive experience in CMC (small molecule programs) within the biotechnology or pharmaceutical industry.
- Proven track record of managing CMC programs, IND/IMPD/NDA filing, and managing CDMOs
- Strong understanding & experience in process chemistry/drug substance/chemical development & drug product.
- Excellent project management and communication skills.
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