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.