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

1. Directly oversee the manufacturing of Capricor’s product candidates for early stage and late-stage clinical trials.
2. 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.
3. Provide strategic and technical direction for technology transfer (internally and/or to a CMO), process development, and optimization activities.
4. Proactively identify knowledge gaps and risks, and work with the team to develop mitigation plans.
5. Collaborate with R&D/PD department to continuously improve manufacturing processes.
6. Oversee supply chain activities to ensure critical raw materials and reagents are made available to ensure timely execution of manufacturing campaigns.
7. Develop manufacturing plans with resources and supervise schedules to meet clinical demand and new clinical trials on cell/gene therapy and/or related platforms.
8. Evaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve company’s products and processes.
9. 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.
10. Work closely with Quality department to ensure compliance with cGMP, ICH, and FDA regulations.
11. Contribute to regulatory filings and interact with regulators as requested to ensure timely start of clinical trials.
12. Define and communicate strategic imperatives to project success.
13. 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.
14. Perform other such duties as may be assigned to you.

Required Skills

1. Bachelor’s degree required (PhD preferred).
2. 8+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry.
3. 5+ years of direct management of manufacturing professionals with a range of responsibilities.
4. Exceptional communication and interpersonal skills.
5. Ability to collect and analyze data and information to determine paths for process improvement and potential root cause.
6. Demonstrated critical thinking and problem-solving skills.
7. Must have full working knowledge of cGMP regulations.
8. 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