Position: Director of Manufacturing

My client is currently seeking an independent, tenacious, science-oriented individual with manufacturing leadership experience and strong coaching skills. The Director of Manufacturing will lead efforts to coordinate the manufacturing and release of cell therapy and exosome products, promote a culture of quality and compliance, and achieve continuous manufacturing successes.

Responsibilities:

Directly oversee the manufacturing of product candidates for early stage and late-stage clinical trials
Lead CMC operations focusing on all areas including but not limited to GMP manufacturing, facility management, procurement, biologics process development, regulatory documentation, validation and change control and supply chain management
Provide strategic and technical direction for technology transfer (internally and/or to a CMO), process development and optimization activities
Proactively identify knowledge gaps and risks, and work with the team to develop mitigation plans
Collaborate with R&D/PD department to continuously improve manufacturing processes
Oversee supply chain activities to ensure critical raw materials and reagents are made available to ensure timely execution of manufacturing campaigns
Develop manufacturing plans with resources and supervise schedules to meet clinical demand and new clinical trials on both the cell therapy and/or exosome platforms
Evaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve Company’s products and processes
Identify and implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance
Work closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations
Contribute to regulatory filings and interact with regulators as requested to ensure timely start of clinical trials
Define and communicate strategic imperatives to project success
Ensure clear communication to Company’s senior management on the status of clinical inventory, manufacturing projects and goals as they relate to cross-functional business success
Perform other such duties as may be assigned to you

Requirements:

Bachelor’s degree required (PhD preferred)
8+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry
5+ years of direct management of manufacturing professionals with increasing levels and/or breadth of responsibility
Exceptional communication and interpersonal skills
Ability to collect and analyze data and information to determine paths for process improvement and potential root cause
Demonstrated critical thinking and problem-solving skills
Must have full working knowledge of cGMP regulations
Must have a strong scientific background with deep knowledge of biologics, cell therapy, and nucleic acid (mRNA) experience a plus

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