Director, CMC

3 weeks ago

Boston, United States Zevra Therapeutics Full time

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.

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