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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