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:
82465
Location:
San Diego,US
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
* Ensures that all tech transfers into manufacturing are controlled and
executed within GMP regulatory guidelines
* Supports Manufacturing group and troubleshoots production activities to
ensure safe, quality, and timely manufacture of biopharmaceutical product for
pre-clinical, clinical and commercial use
* Creates (as needed) and reviews 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
* Participates 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 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
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
* Exceptional communication and interpersonal skills
* Ability to work in a dynamic environment, multi-task, and prioritize work
* Demonstrated critical thinking and problem-solving skills
* Must have full working knowledge of cGMP regulations
* Must have a strong scientific background with deep knowledge of biologics
and cell therapy. Molecular biology experience is a plus.
Application Deadline:
2024-08-26
#J-18808-Ljbffr
Job Number:
82465
Location:
San Diego,US
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
* Ensures that all tech transfers into manufacturing are controlled and
executed within GMP regulatory guidelines
* Supports Manufacturing group and troubleshoots production activities to
ensure safe, quality, and timely manufacture of biopharmaceutical product for
pre-clinical, clinical and commercial use
* Creates (as needed) and reviews 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
* Participates 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 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
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
* Exceptional communication and interpersonal skills
* Ability to work in a dynamic environment, multi-task, and prioritize work
* Demonstrated critical thinking and problem-solving skills
* Must have full working knowledge of cGMP regulations
* Must have a strong scientific background with deep knowledge of biologics
and cell therapy. Molecular biology experience is a plus.
Application Deadline:
2024-08-26
#J-18808-Ljbffr