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Director of CMC Operations

2 months ago

California, United States Meet Full time

Title: Senior Director, CMC

Overview: A forward-thinking clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in guiding and managing CMC functions associated with the development, manufacturing, and supply chain of drug substances and products. This position demands extensive knowledge in the development and commercialization of small molecules, along with a solid grasp of regulatory standards for therapeutics targeting rare diseases.

Key Responsibilities

  • Oversee the design, enhancement, and scaling of drug substance and product processes to ensure efficient and scalable manufacturing for both clinical and commercial applications.
  • Guarantee that all CMC operations adhere to regulatory standards (FDA, EMA, etc.) and industry best practices.
  • Direct the establishment of supply chain resources, partnerships, and protocols essential for successful commercialization.
  • Assist in drafting and reviewing CMC components of regulatory submissions, including IND, BLA, NDA, and MAA.
  • Act as the company representative during regulatory discussions and inspections pertaining to 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 effective, scalable, and economical manufacturing of drug substances and products throughout the commercialization process.
  • Build and sustain robust relationships with external partners, including CMOs, CROs, and suppliers.
  • Negotiate agreements and oversee external vendors to secure high-quality outcomes.
  • Conduct demand forecasting, project management, supply chain oversight, and budget administration.
  • Establish and implement external manufacturing policies, business practices, and systems.
  • Coordinate interdisciplinary teams, including R&D, quality assurance, regulatory affairs, and clinical departments, to facilitate CMC activities.
  • Develop contingency strategies as necessary and communicate challenges, risks, and proposed solutions; execute agreed-upon strategies promptly.
  • Guide and mentor team members, fostering 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 strong emphasis on small molecules and a focus on rare disease product commercialization preferred.
  • Extensive experience in managing outsourced drug substance clinical development through to commercialization is essential, particularly with solid oral dosage forms, modified-release formulations, and pediatric formulations.
  • Significant experience in overseeing US CRO/CMOs for the production of cGMP DSs and DPs; experience with international CROs/CMOs is advantageous.
  • Familiarity with GMP quality systems.
  • Possess strong project leadership capabilities, excellent organizational skills, and meticulous attention to detail; exceptional written and verbal communication skills are required.
  • Demonstrate strong technical judgment; a proactive problem solver with the ability to identify and manage potential risks across all relevant domains.
  • Comprehensive knowledge of regulatory requirements and guidelines governing drug development and manufacturing.
  • Exemplary leadership, communication, and interpersonal skills.
  • Ability to thrive in a fast-paced, dynamic environment.
  • Willingness to travel as necessary.