Director of Manufacturing

Job Title: Director of Manufacturing

Job Number: 85183

Location: San Diego, US

Job Description

The Director of Manufacturing will be a leader in the company who will coordinate the manufacturing and release of our cell therapy products

Responsibilities

* Directly oversee the manufacturing of Capricor’s 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 cell/gene therapy and/or related 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

Required Skills

* 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 a range of responsibilities  * 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 knowledge of biologics, cell or gene therapy, and nucleic acid (mRNA) experience a plus

Application Deadline: 2024-11-04