Job Description
Job Description
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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18 days ago