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The University of Texas MD Anderson Cancer Center

Director of Manufacturing

The University of Texas MD Anderson Cancer Center, San Diego, California, United States, 92189


Job Title: Director of Manufacturing

Job Number:

35419

Location:

San Diego,CA

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

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