Manufacturing Director

1 week ago

San Diego, California, United States Trova Talent Full time
Job Title: Director of Manufacturing

Our client is seeking a seasoned manufacturing professional to lead their cell therapy and exosome product development efforts. As Director of Manufacturing, you will be responsible for overseeing the production of product candidates for early stage and late-stage clinical trials, ensuring compliance with cGMP regulations, and driving continuous manufacturing successes.

Key Responsibilities:
  • Directly oversee the manufacturing of product candidates for early stage and late-stage clinical trials
  • Lead CMC operations, including GMP manufacturing, facility management, procurement, biologics process development, regulatory documentation, validation, and change control
  • Provide strategic and technical direction for technology transfer, 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 available for 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 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
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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