Senior Manufacturing Manager, Cell Therapy - Bristol Myers Squibb
Devens, MA
About the Job
Working with Us
Challenging. 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:
BMS is seeking a dynamic and experienced Senior Manager of Cell Therapy Manufacturing to join our state-of-the-art facility in Devens, MA. In this pivotal role, you will support and drive the commercial operations of our cutting-edge cell therapy manufacturing unit. As the Senior Manager, you will lead a dedicated team responsible for the production of both clinical and commercial cell therapy products, ensuring seamless 24/7 operations. Your oversight will encompass critical processes such as media preparation, cell selection, cell processing, and product fill, all executed in strict adherence to Current Good Manufacturing Practices (cGMPs). Join us in our mission to deliver innovative and life-changing therapies to patients worldwide.
Evening Shifts, 4pm-3am
4-10s, Sun-Wed OR Wed-Sat
DUTIES AND RESPONSIBILITIES:
Establishes and manages multiple manufacturing teams, shifts and manufacturing areas. This includes:
+ Hiring, mentoring and developing exceptional people: Conducting performance reviews and identifying opportunities for career growth for supervisors and associates.
+ Championing a culture of exceptional teamwork and communication across the organization.
+ Ensuring people have and maintain the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
+ Building effective cross-functional relationships with Quality, Supply Chain, MS&T, EHS and F&E.
+ Ensuring a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements. Models these behaviors every day.
Plans for and executes commercial and clinical operations for a licensed CAR-T product in the Devens CTF Manufacturing Plant. This includes:
+ Establishing department goals, tracking and reporting KPIs, and driving a culture continuous improvement through innovation and implementing lean manufacturing initiatives.
+ Implementing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
+ Building and maintaining a training program for cGMP and manufacturing systems.
+ Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity of the facility for multiple CAR-T products.
+ Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
+ Ensuring on time closure of deviations, CAPAs, and change controls.
+ Championing inspection readiness efforts and initiatives for Right First-Time manufacturing.
+ Establishing team policies, organizational structure, shift structure, and career ladders for Associates, Team Leaders, Supervisors and Managers.
+ Reviewing and approving documents, including standard operating procedures, batch records, material specifications, training materials and validation protocols / reports.
REQUIRED COMPETENCIES:
+ Bachelor's degree in relevant science or engineering discipline, or equivalent in work experience.
+ Knowledge of Lean Manufacturing principles required.
+ Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
+ Ability to work in the vicinity of strong magnets.
+ 12+ years of relevant work experience within pharmaceutical or a similarly regulated industry
+ 8+ years of direct experience in cGMP biologics and/or cell therapy manufacturing
+ 6+ years supervising staff in a management role
+ Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques
+ Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues
+ Independent decision-making capability and ability to think conceptually and understand impact of decisions
+ Technical writing capability and experience with writing, approving and training staff on SOPs, Batch Records, Change Controls, deviations and CAPAs.
+ Proficient in MS Office applications
+ Background to include an understanding of biology, chemistry, medical or clinical practices
+ Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
BMSCART
#LI-Onsite
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 Careers
With a single vision as inspiring as Transforming patients' lives through science™ , 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 Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586722
Updated: 2024-11-01 04:00:44.685 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. 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:
BMS is seeking a dynamic and experienced Senior Manager of Cell Therapy Manufacturing to join our state-of-the-art facility in Devens, MA. In this pivotal role, you will support and drive the commercial operations of our cutting-edge cell therapy manufacturing unit. As the Senior Manager, you will lead a dedicated team responsible for the production of both clinical and commercial cell therapy products, ensuring seamless 24/7 operations. Your oversight will encompass critical processes such as media preparation, cell selection, cell processing, and product fill, all executed in strict adherence to Current Good Manufacturing Practices (cGMPs). Join us in our mission to deliver innovative and life-changing therapies to patients worldwide.
Evening Shifts, 4pm-3am
4-10s, Sun-Wed OR Wed-Sat
DUTIES AND RESPONSIBILITIES:
Establishes and manages multiple manufacturing teams, shifts and manufacturing areas. This includes:
+ Hiring, mentoring and developing exceptional people: Conducting performance reviews and identifying opportunities for career growth for supervisors and associates.
+ Championing a culture of exceptional teamwork and communication across the organization.
+ Ensuring people have and maintain the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
+ Building effective cross-functional relationships with Quality, Supply Chain, MS&T, EHS and F&E.
+ Ensuring a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements. Models these behaviors every day.
Plans for and executes commercial and clinical operations for a licensed CAR-T product in the Devens CTF Manufacturing Plant. This includes:
+ Establishing department goals, tracking and reporting KPIs, and driving a culture continuous improvement through innovation and implementing lean manufacturing initiatives.
+ Implementing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
+ Building and maintaining a training program for cGMP and manufacturing systems.
+ Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity of the facility for multiple CAR-T products.
+ Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
+ Ensuring on time closure of deviations, CAPAs, and change controls.
+ Championing inspection readiness efforts and initiatives for Right First-Time manufacturing.
+ Establishing team policies, organizational structure, shift structure, and career ladders for Associates, Team Leaders, Supervisors and Managers.
+ Reviewing and approving documents, including standard operating procedures, batch records, material specifications, training materials and validation protocols / reports.
REQUIRED COMPETENCIES:
+ Bachelor's degree in relevant science or engineering discipline, or equivalent in work experience.
+ Knowledge of Lean Manufacturing principles required.
+ Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
+ Ability to work in the vicinity of strong magnets.
+ 12+ years of relevant work experience within pharmaceutical or a similarly regulated industry
+ 8+ years of direct experience in cGMP biologics and/or cell therapy manufacturing
+ 6+ years supervising staff in a management role
+ Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques
+ Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues
+ Independent decision-making capability and ability to think conceptually and understand impact of decisions
+ Technical writing capability and experience with writing, approving and training staff on SOPs, Batch Records, Change Controls, deviations and CAPAs.
+ Proficient in MS Office applications
+ Background to include an understanding of biology, chemistry, medical or clinical practices
+ Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
BMSCART
#LI-Onsite
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 Careers
With a single vision as inspiring as Transforming patients' lives through science™ , 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 Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586722
Updated: 2024-11-01 04:00:44.685 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
