Sr. Manager/Associate Director, CMC Operations
Responsible for providing chemistry, manufacturing and control (CMC) project management for Mirati’s development programs. A key objective of this position is to efficiently integrate multiple interdisciplinary activities associated with analytical, drug substance and drug product development and develop risk-based strategies to advance candidates to clinical trials according to established timelines. Responsibilities include implementing, managing and providing operational support of manufacturing activities related to supply chain management, inventory planning and packaging and labeling. This individual will work closely with internal departments, third party manufacturers and vendors to plan production and develop/manage risk mitigation plans to any supply chain risks. Additional responsibilities may include but are not limited to the following; CMC technical reviews, coordinating the distribution, packaging and labelling of clinical trial materials within supply chain, managing all CMC contracts and monthly/quarterly budget accrual, and assisting in the review of the CMC sections of regulatory health authority submissions.
- Oversee the shipment of starting materials, drug substance and drug product from inception to the clinical packaging and labeling sites and distribution depots
- Manage third party manufacturers and ensure activities and deliverables are aligned to avoid disruptions within Supply Chain.
- As a member of CMC department, manage and update project/clinical plans and schedules to support development team objectives and clinical forecasts and demands
- Identify risks to CMC timelines and/or budgets relating to CMC activities
- Participate in periodic business and technical review meetings with CMOs
- Oversee/manage all CMC contracts including MSAs, NDAs and work orders related to DS/DP manufacturing, product development and analytical activities
- Participate as CMC representative during regular Finance accrual meetings
- Coordinate with Analytical Sciences, Chemical R&D and Product R&D in the establishment of CMC analytical and process develop laboratories, including equipment procurement and management of equipment qualification/calibration/validation activities and related contracts
- BS/MS with >10 years of experience chemistry, biochemistry, chemical engineering, biomedical engineering, pharmaceutical sciences or closely related discipline with relevant solid oral drug product development experience
- Knowledge of current Good Manufacturing Practices (cGMP)
- Demonstrated knowledge of small molecule drug product development and validation, CMO contract management and project management
- Established project management skills and proven ability to effectively organize and prioritize tasks
- Ability to adapt rapidly and change focus based on real-time results and findings
- Exceptional written, verbal communication and interpersonal skills