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Director of Manufacturing

2 months ago

San Diego, United States Trova Talent Full time
Job DescriptionJob DescriptionPosition: 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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