Director/Sr. Director of Drug Product CMC
Location: New York City, NY
Company Overview:
We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies.
Job Summary:
The Director/Sr. Director of Drug Product CMC will lead and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Director/Sr. Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones.
Key Responsibilities:
- Lead the development and implementation of CMC strategies for drug product development and manufacturing.
- Oversee technology transfer to and from contract manufacturing organizations (CMOs) and provide technical oversight of drug product manufacturing.
- Ensure compliance with cGMP regulations and manage quality assurance activities, including deviation management, batch record reviews, and lot disposition.
- Develop and manage risk-based strategies for CMO oversight, considering product lifecycle, technical complexity, and CMO capabilities.
- Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Clinical Development, and Supply Chain, to ensure timely delivery of drug products.
- Support regulatory submissions by providing CMC-related documentation and expertise.
- Lead process optimization, validation, and continuous improvement initiatives.
- Manage the drug product manufacturing budget and long-range planning.
- Serve as a subject matter expert during regulatory inspections and audits.
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.).
- Strong knowledge of cGMP regulations, ICH guidelines, and CMC content of regulatory submissions.
- Proven track record in CMC regulatory submissions (IND, NDA)
- Experience managing CMOs and overseeing technology transfer processes.
- Excellent problem-solving, project management, and communication skills.
- Ability to work collaboratively in a fast-paced, dynamic environment.
- Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE.
- Willingness to travel as needed (up to 10%).
What We Offer:
- Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies.
- Collaborative work environment with professional development and career growth opportunities.
- Competitive compensation package, including comprehensive benefits and stock options.
