Senior CMC Director
1 week ago
Title: Senior Director, CMC
Overview: A progressive clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in directing and managing CMC initiatives pertaining to the development, manufacturing, and supply chain of drug substances and products. This position demands extensive knowledge in the development and commercialization of small molecule pharmaceuticals, along with a comprehensive understanding of regulatory frameworks for therapeutics targeting rare diseases.
Key Responsibilities:
- Oversee the design, enhancement, and scaling of drug substance and product processes, ensuring the establishment of reliable and scalable manufacturing methods for both clinical and commercial outputs.
- Guarantee that all CMC operations adhere to regulatory standards (FDA, EMA, etc.) and industry best practices.
- Lead the establishment of supply chain resources, partnerships, and protocols essential for successful commercialization.
- Contribute to the drafting and evaluation of CMC sections in regulatory submissions, including IND, BLA, NDA, and MAA.
- Act as the company representative during regulatory discussions and inspections concerning CMC operations.
- Provide technical leadership and manage Contract Manufacturing Organizations (CMOs) to optimize processes, ensure cGMP manufacturing, and supply Drug Substance (DS) and Drug Product (DP) in support of ongoing clinical initiatives through to commercialization.
- Ensure efficient, scalable, and cost-effective manufacturing of drug substances and products throughout the commercialization process.
- Build and sustain strong partnerships with external collaborators, including CMOs, CROs, and suppliers.
- Negotiate agreements and oversee external vendors to guarantee high-quality outcomes.
- Conduct demand forecasting, project management, supply chain oversight, and budget administration.
- Define and implement external manufacturing protocols, business processes, and systems.
- Coordinate cross-functional teams, including R&D, quality assurance, regulatory affairs, and clinical operations, to facilitate CMC activities.
- Prepare contingency strategies as necessary and communicate challenges, risks, and proposed solutions; execute agreed-upon strategies promptly.
- Mentor and cultivate team members, offering guidance and support for their professional development.
Qualifications:
- Master's degree or Ph.D. in chemical engineering, chemistry, organic chemistry, or a related scientific field.
- At least 10-15 years of experience in CMC drug substance or product development and manufacturing, with a focus on small molecules and rare disease product commercialization preferred.
- Strong expertise in outsourced drug substance clinical development through to commercialization is essential, particularly with solid oral dosage forms, modified-release formulations, and pediatric formulations.
- Significant experience managing US CRO/CMOs for the production of cGMP DSs and DPs; experience with international CROs/CMOs is advantageous.
- In-depth knowledge of GMP quality systems.
- Demonstrated project leadership capabilities with exceptional organizational skills and meticulous attention to detail; outstanding written and verbal communication skills are required.
- Possess strong technical judgment; a proactive problem solver with the ability to identify and manage potential risks across all relevant domains.
- Comprehensive understanding of regulatory requirements and guidelines for drug development and manufacturing.
- Exceptional leadership, communication, and interpersonal skills.
- Ability to thrive in a fast-paced, dynamic environment.
- Willingness to travel as necessary.
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