Director, MS&T Cell Therapy Process Support
Working 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.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
PURPOSE AND SCOPE OF POSITION:
The Director Cell Therapy Process Support leads a cross-functional team responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply.
Oversees the process support, technology transfer and lifecycle management functions.
Provides technical and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.
The organization being supported is a 24x7x365 manufacturing facility.
Work scope will include commercial manufacturing and clinical manufacturing for cell therapy product.
This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and global MS&T.
This position is based in Devens, MA.
DUTIES AND
Responsibilities:
Ensure safe and compliant cGMP operations Maintain permanent inspection readiness and actively support regulatory inspections Support optimization of the organizational structure to maximize productivity and communication flow Support Devens MS&T Lead in developing productivity and financial goals with the cross-functional team Implement metrics to track and manage completion of objectives and projects Allocate resources to ensure supply plans are met within the planned schedule and budget Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production Support production related investigations, ensuring compliance with internal standards and regulatory requirements Interface with regulatory authorities as required to support Manufacturing Operations audits Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel and equipment are in place.
Stay current with industry trends and standards (e.
g.
PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
Select and develop a well-trained, motivated and informed staff.
Leadership:
Create an environment of teamwork, open communication, and a sense of urgency Lead as a change agent to promote flexibility, creativity, and accountability Cascade organizational strategic goals and objectives that are linked to the overall company strategy 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 Foster a culture of compliance and strong environmental, health, and safety performance Promote a mindset of continuous improvement, problem solving, and prevention REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
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 Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies Experience working with external parties and/or leading cross-functional teams Project management experience leading multi-functional and multi-location teams 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 Education and
Experience:
Bachelor's Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred 15 or more years of work experience in the biopharmaceutical or related industry 8 or more years of people management experience 8 or more years of manufacturing support or related experience in the biopharmaceutical industry WORKING CONDITIONS (US Only):
The incumbent will be required to gown to access classified manufacturing areas.
Staff reporting and supported by this position will work in a 24x7 schedule, and this role must be capable of interfacing at appropriate intervals with all staff.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
Employees holding this position will be required to perform any other job-related duties as requested by management.
BMSCART#LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Auditing Automation Business Process Improvement Cell Therapy Cleanrooms Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
careers.
bms.
com/working-with-us.
PURPOSE AND SCOPE OF POSITION:
The Director Cell Therapy Process Support leads a cross-functional team responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply.
Oversees the process support, technology transfer and lifecycle management functions.
Provides technical and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.
The organization being supported is a 24x7x365 manufacturing facility.
Work scope will include commercial manufacturing and clinical manufacturing for cell therapy product.
This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and global MS&T.
This position is based in Devens, MA.
DUTIES AND
Responsibilities:
Ensure safe and compliant cGMP operations Maintain permanent inspection readiness and actively support regulatory inspections Support optimization of the organizational structure to maximize productivity and communication flow Support Devens MS&T Lead in developing productivity and financial goals with the cross-functional team Implement metrics to track and manage completion of objectives and projects Allocate resources to ensure supply plans are met within the planned schedule and budget Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production Support production related investigations, ensuring compliance with internal standards and regulatory requirements Interface with regulatory authorities as required to support Manufacturing Operations audits Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel and equipment are in place.
Stay current with industry trends and standards (e.
g.
PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
Select and develop a well-trained, motivated and informed staff.
Leadership:
Create an environment of teamwork, open communication, and a sense of urgency Lead as a change agent to promote flexibility, creativity, and accountability Cascade organizational strategic goals and objectives that are linked to the overall company strategy 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 Foster a culture of compliance and strong environmental, health, and safety performance Promote a mindset of continuous improvement, problem solving, and prevention REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
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 Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies Experience working with external parties and/or leading cross-functional teams Project management experience leading multi-functional and multi-location teams 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 Education and
Experience:
Bachelor's Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred 15 or more years of work experience in the biopharmaceutical or related industry 8 or more years of people management experience 8 or more years of manufacturing support or related experience in the biopharmaceutical industry WORKING CONDITIONS (US Only):
The incumbent will be required to gown to access classified manufacturing areas.
Staff reporting and supported by this position will work in a 24x7 schedule, and this role must be capable of interfacing at appropriate intervals with all staff.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
Employees holding this position will be required to perform any other job-related duties as requested by management.
BMSCART#LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Auditing Automation Business Process Improvement Cell Therapy Cleanrooms Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
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