Bristol-Myers Squibb
Senior Director, Manufacturing Science and Technology
Bristol-Myers Squibb, Summit, New Jersey, us, 07902
Senior Director, Manufacturing Science and TechnologyWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
The
Senior Director, Cell Therapy Manufacturing Technology
leads a cross-functional team responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Summit, NJ Cell Therapy production facility is a multi-product operation. This role oversees the operations investigation team, product launch, technology transfer, validation and cell therapy Automation / MES. This position provides technical and continuous improvement support to the startup, tech transfer and operation of the Cell Therapy production facility in Summit, NJ to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. This is a critical role to ensure timely qualification of the cell therapy operations (CTO) facility and continued reliable supply. The role will work closely with the global Manufacturing Science & Technology leadership and CMC functions to standardize CTO practices and ensure that the process remains in a validated state.
Shifts Available:Monday – Friday, Standard Working Hours
Responsibilities:
Foster a culture of compliance and technical expertise with a foundation of strong environmental, health, and safety performance.
Build and maintain inspection readiness and actively support regulatory inspections, interface with regulatory authorities as required to support pre-license inspections and subsequent routine GMP inspections.
Build and evolve the organizational structure to maximize productivity and organizational success in the design, construction, validation, and operation of the Summit Cell Therapy manufacturing facility. Select and develop a well-trained, motivated, and informed staff.
Develop, implement, and monitor metrics to track and manage completion of objectives and projects.
Allocate resources to ensure supply plans are met within the planned schedule and budget.
Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel, and equipment are in place.
Work with key partner organizations such as Manufacturing, Quality, and Facilities & Engineering to build and maintain efficient systems that support the safe, successful, and compliant startup, technical transfer, and operation of a clinical and commercial Cell Therapy manufacturing facility.
Collaborate with BMS Network Cell Therapy manufacturing facilities to ensure consistent performance and compliance to meet reliable supply.
Lead a Validation team that will:
Provide technical leadership for the commissioning, qualification, and validation of the Summit Cell Therapy manufacturing facility with a focus on clean room technology and Aseptic Qualification.Partner with Summit Facilities and Engineering to establish systems that will maintain a compliant, validated state for the Manufacturing facility.
Lead a team of Automation engineers that will:
Manage stand-alone manufacturing equipment.Support the design, build, deploy, validate, and support both automation and execution systems (Delta V, Syncade, MES, EBR, OSI Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment.Lead the life cycle management and integration of electronic GMP manufacturing systems.
Lead the Manufacturing Support and Process engineering function with a focus on:
Provide technical leadership for the design, construction, validation, and operation of the Summit Cell Therapy manufacturing facility.Building and maintaining systems to continuously monitor, analyze, and optimize the end-to-end process performance.Anticipating and permanently resolving issues that may arise during production.Partnering with QA and Manufacturing to ensure efficient and compliant cGMP systems to support manufacturing, including change control, investigations, etc.
Lead the Operations Investigation team:
Provide technical support to site operations through determination of root cause investigations.Determination of suitable CAPA to prevent recurrence of events.Partnering with QA, Manufacturing, Supply Chain, Facilities and Engineering to ensure efficient and compliant cGMP systems to support manufacturing, including change control, investigations, etc.
Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.
Working with Global MS&T groups, execute/implement standardized CTDO practices and Life Cycle Management projects in manufacturing in alignment with the overall network plans.
Maintain and understanding of current industry trends and regulatory standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
Create an environment of teamwork, open communication, and a sense of urgency, lead as a change agent to promote flexibility, creativity, and accountability.
Drive strong collaboration within the plant and across the network.
Build trust and effective relationships with peers and stakeholders.
Deliver business results through timely and quality decision making and advice.
Promote a mindset of continuous improvement and problem solving.
Knowledge & Skills:
Expert knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations.
Deep knowledge of facility/clean room design, process, equipment, automation, and validation.
Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.
Demonstrated ability to build people, processes, and technology in a complex, global, and technical organization.
Experience leading regulatory inspections.
Experience utilizing a Quality Management System (QMS).
Hands-on experience with and broad knowledge of single-use technologies, closed systems, and cold chain/cryogenic technologies.
Experience leading teams of manufacturing technical experts, engineers and/or scientists.
Possess strong verbal/written communication skills and ability to influence at all levels.
Ability to think strategically and to translate strategy into actions.
Ability to prioritize and provide clear direction to team members in a highly dynamic environment.
Experience with Operational Excellence and Lean Manufacturing, Green Belt or Black Belt a plus.
Basic Requirements:
Bachelor’s degree in relevant science or engineering discipline, advanced degree in a relevant science or engineering discipline preferred.
15+ years of work experience in the biopharmaceutical or related industry. Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T, or Technical Development.
Minimum 10 years of direct experience in GMP environment and manufacturing site-based MS&T experience.
10+ years of people management experience.
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The
Senior Director, Cell Therapy Manufacturing Technology
leads a cross-functional team responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Summit, NJ Cell Therapy production facility is a multi-product operation. This role oversees the operations investigation team, product launch, technology transfer, validation and cell therapy Automation / MES. This position provides technical and continuous improvement support to the startup, tech transfer and operation of the Cell Therapy production facility in Summit, NJ to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. This is a critical role to ensure timely qualification of the cell therapy operations (CTO) facility and continued reliable supply. The role will work closely with the global Manufacturing Science & Technology leadership and CMC functions to standardize CTO practices and ensure that the process remains in a validated state.
Shifts Available:Monday – Friday, Standard Working Hours
Responsibilities:
Foster a culture of compliance and technical expertise with a foundation of strong environmental, health, and safety performance.
Build and maintain inspection readiness and actively support regulatory inspections, interface with regulatory authorities as required to support pre-license inspections and subsequent routine GMP inspections.
Build and evolve the organizational structure to maximize productivity and organizational success in the design, construction, validation, and operation of the Summit Cell Therapy manufacturing facility. Select and develop a well-trained, motivated, and informed staff.
Develop, implement, and monitor metrics to track and manage completion of objectives and projects.
Allocate resources to ensure supply plans are met within the planned schedule and budget.
Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel, and equipment are in place.
Work with key partner organizations such as Manufacturing, Quality, and Facilities & Engineering to build and maintain efficient systems that support the safe, successful, and compliant startup, technical transfer, and operation of a clinical and commercial Cell Therapy manufacturing facility.
Collaborate with BMS Network Cell Therapy manufacturing facilities to ensure consistent performance and compliance to meet reliable supply.
Lead a Validation team that will:
Provide technical leadership for the commissioning, qualification, and validation of the Summit Cell Therapy manufacturing facility with a focus on clean room technology and Aseptic Qualification.Partner with Summit Facilities and Engineering to establish systems that will maintain a compliant, validated state for the Manufacturing facility.
Lead a team of Automation engineers that will:
Manage stand-alone manufacturing equipment.Support the design, build, deploy, validate, and support both automation and execution systems (Delta V, Syncade, MES, EBR, OSI Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment.Lead the life cycle management and integration of electronic GMP manufacturing systems.
Lead the Manufacturing Support and Process engineering function with a focus on:
Provide technical leadership for the design, construction, validation, and operation of the Summit Cell Therapy manufacturing facility.Building and maintaining systems to continuously monitor, analyze, and optimize the end-to-end process performance.Anticipating and permanently resolving issues that may arise during production.Partnering with QA and Manufacturing to ensure efficient and compliant cGMP systems to support manufacturing, including change control, investigations, etc.
Lead the Operations Investigation team:
Provide technical support to site operations through determination of root cause investigations.Determination of suitable CAPA to prevent recurrence of events.Partnering with QA, Manufacturing, Supply Chain, Facilities and Engineering to ensure efficient and compliant cGMP systems to support manufacturing, including change control, investigations, etc.
Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.
Working with Global MS&T groups, execute/implement standardized CTDO practices and Life Cycle Management projects in manufacturing in alignment with the overall network plans.
Maintain and understanding of current industry trends and regulatory standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
Create an environment of teamwork, open communication, and a sense of urgency, lead as a change agent to promote flexibility, creativity, and accountability.
Drive strong collaboration within the plant and across the network.
Build trust and effective relationships with peers and stakeholders.
Deliver business results through timely and quality decision making and advice.
Promote a mindset of continuous improvement and problem solving.
Knowledge & Skills:
Expert knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations.
Deep knowledge of facility/clean room design, process, equipment, automation, and validation.
Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.
Demonstrated ability to build people, processes, and technology in a complex, global, and technical organization.
Experience leading regulatory inspections.
Experience utilizing a Quality Management System (QMS).
Hands-on experience with and broad knowledge of single-use technologies, closed systems, and cold chain/cryogenic technologies.
Experience leading teams of manufacturing technical experts, engineers and/or scientists.
Possess strong verbal/written communication skills and ability to influence at all levels.
Ability to think strategically and to translate strategy into actions.
Ability to prioritize and provide clear direction to team members in a highly dynamic environment.
Experience with Operational Excellence and Lean Manufacturing, Green Belt or Black Belt a plus.
Basic Requirements:
Bachelor’s degree in relevant science or engineering discipline, advanced degree in a relevant science or engineering discipline preferred.
15+ years of work experience in the biopharmaceutical or related industry. Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T, or Technical Development.
Minimum 10 years of direct experience in GMP environment and manufacturing site-based MS&T experience.
10+ years of people management experience.
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