The University of Texas MD Anderson Cancer Center
AD / Director, MSAT
The University of Texas MD Anderson Cancer Center, San Diego, California, United States, 92189
Job Title:
AD/Director, MSAT
Job Number:
35155
Location:
San Diego, CA
Job Description
We are seeking an experienced, science-oriented individual with manufacturing leadership experience and strong coaching skills. The AD/Director of MSAT will be acting as SME for manufacturing products and will support CMC operations focusing on all areas including but not limited to biologics process development, technology transfers, manufacturing operations, and regulatory documentation.Responsibilities
Provide technical leadership and work cross-functionally to ensure clear communication and act as a Subject Matter Expert (SME) to explain and present scientific information and data relating to both the cell therapy and related platforms.
Ensure that all tech transfers into manufacturing are controlled and executed within GMP regulatory guidelines.
Support Manufacturing group and troubleshoot production activities to ensure safe, quality, and timely manufacture of biopharmaceutical products for pre-clinical, clinical, and commercial use.
Create (as needed) and review all process-related manufacturing SOPs and documentation (batch records and SOPs, bills of material, tech transfer documents, risk assessments, and process flow diagrams) to assure all clinical products meet the requirements for quality, safety, and efficacy.
Perform manufacturing deviation investigations or design GDP experiments to determine root cause.
Provide in-person and real-time manufacturing production support as needed.
Participate in strategic resource and capacity planning for the site to meet clinical and commercial demand on both the cell therapy and/or exosome platforms.
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 in collaboration with R&PD and manufacturing.
Evaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve Company’s products and processes.
Work closely with the Quality department to ensure compliance with cGMP, ICH, and FDA regulations.
Serve as an organizational change agent and foster an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset.
Perform such other duties as may be assigned to you from time to time.
Required Skills
Bachelor’s degree required (Masters or PhD preferred).
8+ years of hands-on cGMP cell therapy manufacturing experience in the pharmaceutical/biotech industry.
5+ years of direct management of manufacturing professionals with increasing levels and/or breadth of responsibility.
Exceptional communication and interpersonal skills.
Ability to collect and analyze data and information to determine paths for process improvement and potential root cause.
Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles, and collaboration with others.
Must have full working knowledge of cGMP regulations.
Must have a strong scientific background with deep knowledge of biologics, cell therapy, and nucleic acid (mRNA) experience a plus.
Ability to work in a dynamic environment, multi-task, and prioritize work.
Demonstrated critical thinking and problem-solving skills.
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AD/Director, MSAT
Job Number:
35155
Location:
San Diego, CA
Job Description
We are seeking an experienced, science-oriented individual with manufacturing leadership experience and strong coaching skills. The AD/Director of MSAT will be acting as SME for manufacturing products and will support CMC operations focusing on all areas including but not limited to biologics process development, technology transfers, manufacturing operations, and regulatory documentation.Responsibilities
Provide technical leadership and work cross-functionally to ensure clear communication and act as a Subject Matter Expert (SME) to explain and present scientific information and data relating to both the cell therapy and related platforms.
Ensure that all tech transfers into manufacturing are controlled and executed within GMP regulatory guidelines.
Support Manufacturing group and troubleshoot production activities to ensure safe, quality, and timely manufacture of biopharmaceutical products for pre-clinical, clinical, and commercial use.
Create (as needed) and review all process-related manufacturing SOPs and documentation (batch records and SOPs, bills of material, tech transfer documents, risk assessments, and process flow diagrams) to assure all clinical products meet the requirements for quality, safety, and efficacy.
Perform manufacturing deviation investigations or design GDP experiments to determine root cause.
Provide in-person and real-time manufacturing production support as needed.
Participate in strategic resource and capacity planning for the site to meet clinical and commercial demand on both the cell therapy and/or exosome platforms.
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 in collaboration with R&PD and manufacturing.
Evaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve Company’s products and processes.
Work closely with the Quality department to ensure compliance with cGMP, ICH, and FDA regulations.
Serve as an organizational change agent and foster an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset.
Perform such other duties as may be assigned to you from time to time.
Required Skills
Bachelor’s degree required (Masters or PhD preferred).
8+ years of hands-on cGMP cell therapy manufacturing experience in the pharmaceutical/biotech industry.
5+ years of direct management of manufacturing professionals with increasing levels and/or breadth of responsibility.
Exceptional communication and interpersonal skills.
Ability to collect and analyze data and information to determine paths for process improvement and potential root cause.
Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles, and collaboration with others.
Must have full working knowledge of cGMP regulations.
Must have a strong scientific background with deep knowledge of biologics, cell therapy, and nucleic acid (mRNA) experience a plus.
Ability to work in a dynamic environment, multi-task, and prioritize work.
Demonstrated critical thinking and problem-solving skills.
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