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: 2024-10-28
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