Director, CMC

Job Description
The Director, CMC will develop and manage manufacturing and packaging operations for clinical and commercial drug substance and drug products at contract manufacturing (CMO) facilities.

Job Responsibilities
· Manage and interface with CMOs (including person-in-plant (PIP) activities as needed) to ensure drug substance, finished dosage form and related primary packaging operations are completed in compliance with cGMP requirements.
· Assist with development, review and execution of Supply/Service Agreements and Quality Agreements in coordination with Legal and Quality Assurance
· Interface with Quality Assurance, Clinical/Medical, Supply Chain, and Commercial teams to ensure manufacture of required quantities and timely delivery to meet clinical and commercial demands.
· Establish and manage appropriate timelines and deadlines for both internal and external manufacturing tasks.
· Ensure development and/or technical review of manufacturing documents (batch records, formulation/process data, analytical methods, protocols, reports).
· Provide manufacturing expertise to CMOs during manufacturing campaigns including assistance with troubleshooting as needed.
· Identify manufacturing problems and initiate/coordinate manufacturing investigations with Quality Assurance
· Review technical information for different manufacturing operations and assess deviations. Review routine reports, Non-Conformance and Corrective Action and preventive Action (CAPA). Support internal Quality function with writing and review of internal change management documents.
· Coordinate and plan strategy for continuous process optimization
· Compile CMC related information and draft CMC sections of regulatory submissions

Job Requirements
· A minimum of 8-10 years of pharma/biotech industry experience in drug development including experience in clinical drug development, commercialization, and regulatory knowledge. Minimum of 5-7 years’ experience managing CMOs.
· BS or equivalent experience in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. Masters or Doctorate degrees a plus.
· Strong scientific knowledge and understanding of product development with relevance to pharmaceutical manufacturing including API chemical synthesis, drug product manufacturing, and packaging.
· Knowledge of GMP regulations, ICH guidelines; as well as CMC content of regulatory submissions.
· Knowledge of appropriate analytical methodology used in product characterization
· Familiarity with pharmaceutical supply chain management
· Displays sense of urgency to resolve problems that arise during drug development and manufacturing. Able to develop solutions to complex problems and influence resolution both internally and externally.
· Strong verbal and written communication with solid organizational, time management, and project management skills.
· Ability to work collaboratively, respectfully, and effectively with others.
· Flexible schedule to accommodate regular telecons with CMOs and travel to respective CMO sites.

#J-18808-Ljbffr