Trova Talent
Director of Manufacturing (Life Sciences)
Trova Talent, San Diego, California, United States, 92189
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 trialsLead 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 managementProvide strategic and technical direction for technology transfer (internally and/or to a CMO), process development and optimization activitiesProactively identify knowledge gaps and risks, and work with the team to develop mitigation plansCollaborate with R&D/PD department to continuously improve manufacturing processesOversee supply chain activities to ensure critical raw materials and reagents are made available to ensure timely execution of manufacturing campaignsDevelop manufacturing plans with resources and supervise schedules to meet clinical demand and new clinical trials on both the cell therapy and/or exosome platformsEvaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve Company’s products and processesIdentify 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 complianceWork closely with Quality department to ensure compliance with cGMP, ICH and FDA regulationsContribute to regulatory filings and interact with regulators as requested to ensure timely start of clinical trialsDefine and communicate strategic imperatives to project successEnsure clear communication to Company’s senior management on the status of clinical inventory, manufacturing projects and goals as they relate to cross-functional business successPerform 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 industry5+ years of direct management of manufacturing professionals with increasing levels and/or breadth of responsibilityExceptional communication and interpersonal skillsAbility to collect and analyze data and information to determine paths for process improvement and potential root causeDemonstrated critical thinking and problem-solving skillsMust have full working knowledge of cGMP regulationsMust have a strong scientific background with deep knowledge of biologics, cell therapy, and nucleic acid (mRNA) experience a plus
Powered by JazzHR
gcIsurvIFj#J-18808-Ljbffr
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 trialsLead 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 managementProvide strategic and technical direction for technology transfer (internally and/or to a CMO), process development and optimization activitiesProactively identify knowledge gaps and risks, and work with the team to develop mitigation plansCollaborate with R&D/PD department to continuously improve manufacturing processesOversee supply chain activities to ensure critical raw materials and reagents are made available to ensure timely execution of manufacturing campaignsDevelop manufacturing plans with resources and supervise schedules to meet clinical demand and new clinical trials on both the cell therapy and/or exosome platformsEvaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve Company’s products and processesIdentify 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 complianceWork closely with Quality department to ensure compliance with cGMP, ICH and FDA regulationsContribute to regulatory filings and interact with regulators as requested to ensure timely start of clinical trialsDefine and communicate strategic imperatives to project successEnsure clear communication to Company’s senior management on the status of clinical inventory, manufacturing projects and goals as they relate to cross-functional business successPerform 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 industry5+ years of direct management of manufacturing professionals with increasing levels and/or breadth of responsibilityExceptional communication and interpersonal skillsAbility to collect and analyze data and information to determine paths for process improvement and potential root causeDemonstrated critical thinking and problem-solving skillsMust have full working knowledge of cGMP regulationsMust have a strong scientific background with deep knowledge of biologics, cell therapy, and nucleic acid (mRNA) experience a plus
Powered by JazzHR
gcIsurvIFj#J-18808-Ljbffr