BioSpace
Head of Manufacturing, Cell Therapy
BioSpace, Boston, Massachusetts, us, 02298
Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as The Head of Manufacturing for Cell Therapies. This is a senior level strategic role reporting to the VP of Cell Therapy Sciences at Takeda. The role will have ownership of a fully established clinical cell therapy manufacturing facility and have responsibility to mentor a team of associates comprising manufacturing operations, external manufacturing, Manufacturing Sciences and Analytical Technologies, supply chain and manufacturing systems and validation. This is a strategic level high-visibility position that will be deeply involved in developing the long-term cell therapy roadmap for Takeda. This is an on-site role based out of the Takeda’s Cambridge, Massachusetts site.
How You Will Contribute
Responsible for overseeing the internal manufacturing team to support Takeda’s innovative allogenic cell therapy pipeline.
Oversee all aspects of manufacturing for the Cell Therapy division, including Manufacturing Operations, Manufacturing Sciences and Analytical Technologies, External Manufacturing, Supply Chain and Manufacturing Systems and Validation groups.
Provide technical leadership for the design, construction, validation and operation of Takeda’s new combined cell and viral vector manufacturing facility for Takeda’s new One Research campus.
Provide technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, change control, and product comparability.
Lead the manufacturing and evaluation of clinical trial processes to determine viability of commercial platforms.
Oversee technical content for documents such as tech transfer plan, validation or comparability assessments and regulatory submissions.
Work closely with the Head of Development to synergize and streamline processes, methods and transfers between the PD/AD and MSAT/QC teams, as well as other functions.
Drive External manufacturing excellence and establish technology transfer processes for external partners ensuring readiness for cGMP operations.
Develop a network strategy for external manufacturing of critical materials with appropriate redundancy and risk mitigation strategies.
Define phase appropriate supply chain tools for efficient distribution of cell therapy drug products globally and develop the roadmap for a digital supply chain strategy.
Effectively partner with Quality, Facilities and other functions to develop and maintain processes for effectively releasing drug product into the clinic.
Extensively collaborate with other functional teams – Process Development, Automation, Digital Technologies to implement innovative solutions that drive efficiency.
Work closely with the Development team to devise and implement a manufacturing technology roadmap and identify key areas of investment to maximize efficiency and product quality.
Lead all efforts to develop and comply with departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and lead the establishment and maintenance of departmental Quality systems.
Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and other governing bodies and present technical strategies during health authority interactions and inspections.
Provide development, coaching, training and administration of performance management to personnel.
Develop and manage budgets, participate in annual financial forecasting and ensure adherence to Takeda financial targets.
Foster a culture of safety, quality, and continuous learning within the manufacturing team.
Minimum Requirements/Qualifications
B.S., M.S. or Ph.D in Engineering or life science with 15+ years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations.
Previous hands-on experience in a cell therapy cGMP environment is required.
Experience in design, construction and set-up/validation of new cell therapy manufacturing facilities is essential.
Highly familiar with aseptic processing, expansion and differentiation of cell therapy products, generation of viral vectors and formulation of cellular therapeutics.
Previous experience in managing technical interactions with CMOs, manufacturing of cell therapies, or product life cycle management is required.
Experience in analytical method validation, transfer, and quality control in accordance with regulatory guidelines and industry standards is preferred.
Experience in supply chain planning, SAP ERP system, supply network strategy and optimization is preferred.
Extensive experience in set up and validation of manufacturing systems and technology.
Deep understanding of cGMP Directives, industry guidelines and applicable agency regulation (FDA, EMA, etc.) particularly as they relate to cell and gene therapy.
Proven track record of leadership skills, ability to communicate and partner well with all levels of staff, extensive experience in building teams and ability to lead and motivate team members with emphasis on compliance and continuous improvement and to resolve conflicts.
Knowledge And Skills
Teamwork – Ability to work well in a highly cross-functional team environment.
Communication – Able to express one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor.
Analytical and Problem Solving Skills – Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously.
Motivated – Self-motivated and willing to accept temporary responsibilities outside of initial job description.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as The Head of Manufacturing for Cell Therapies. This is a senior level strategic role reporting to the VP of Cell Therapy Sciences at Takeda. The role will have ownership of a fully established clinical cell therapy manufacturing facility and have responsibility to mentor a team of associates comprising manufacturing operations, external manufacturing, Manufacturing Sciences and Analytical Technologies, supply chain and manufacturing systems and validation. This is a strategic level high-visibility position that will be deeply involved in developing the long-term cell therapy roadmap for Takeda. This is an on-site role based out of the Takeda’s Cambridge, Massachusetts site.
How You Will Contribute
Responsible for overseeing the internal manufacturing team to support Takeda’s innovative allogenic cell therapy pipeline.
Oversee all aspects of manufacturing for the Cell Therapy division, including Manufacturing Operations, Manufacturing Sciences and Analytical Technologies, External Manufacturing, Supply Chain and Manufacturing Systems and Validation groups.
Provide technical leadership for the design, construction, validation and operation of Takeda’s new combined cell and viral vector manufacturing facility for Takeda’s new One Research campus.
Provide technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, change control, and product comparability.
Lead the manufacturing and evaluation of clinical trial processes to determine viability of commercial platforms.
Oversee technical content for documents such as tech transfer plan, validation or comparability assessments and regulatory submissions.
Work closely with the Head of Development to synergize and streamline processes, methods and transfers between the PD/AD and MSAT/QC teams, as well as other functions.
Drive External manufacturing excellence and establish technology transfer processes for external partners ensuring readiness for cGMP operations.
Develop a network strategy for external manufacturing of critical materials with appropriate redundancy and risk mitigation strategies.
Define phase appropriate supply chain tools for efficient distribution of cell therapy drug products globally and develop the roadmap for a digital supply chain strategy.
Effectively partner with Quality, Facilities and other functions to develop and maintain processes for effectively releasing drug product into the clinic.
Extensively collaborate with other functional teams – Process Development, Automation, Digital Technologies to implement innovative solutions that drive efficiency.
Work closely with the Development team to devise and implement a manufacturing technology roadmap and identify key areas of investment to maximize efficiency and product quality.
Lead all efforts to develop and comply with departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and lead the establishment and maintenance of departmental Quality systems.
Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and other governing bodies and present technical strategies during health authority interactions and inspections.
Provide development, coaching, training and administration of performance management to personnel.
Develop and manage budgets, participate in annual financial forecasting and ensure adherence to Takeda financial targets.
Foster a culture of safety, quality, and continuous learning within the manufacturing team.
Minimum Requirements/Qualifications
B.S., M.S. or Ph.D in Engineering or life science with 15+ years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations.
Previous hands-on experience in a cell therapy cGMP environment is required.
Experience in design, construction and set-up/validation of new cell therapy manufacturing facilities is essential.
Highly familiar with aseptic processing, expansion and differentiation of cell therapy products, generation of viral vectors and formulation of cellular therapeutics.
Previous experience in managing technical interactions with CMOs, manufacturing of cell therapies, or product life cycle management is required.
Experience in analytical method validation, transfer, and quality control in accordance with regulatory guidelines and industry standards is preferred.
Experience in supply chain planning, SAP ERP system, supply network strategy and optimization is preferred.
Extensive experience in set up and validation of manufacturing systems and technology.
Deep understanding of cGMP Directives, industry guidelines and applicable agency regulation (FDA, EMA, etc.) particularly as they relate to cell and gene therapy.
Proven track record of leadership skills, ability to communicate and partner well with all levels of staff, extensive experience in building teams and ability to lead and motivate team members with emphasis on compliance and continuous improvement and to resolve conflicts.
Knowledge And Skills
Teamwork – Ability to work well in a highly cross-functional team environment.
Communication – Able to express one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor.
Analytical and Problem Solving Skills – Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously.
Motivated – Self-motivated and willing to accept temporary responsibilities outside of initial job description.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#J-18808-Ljbffr