Senior Director, Manufacturing Science and Technology
Industrial work / Manufacturing
Full Time
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:
This role leads the Manufacturing Science and Technology (MSAT) team of 50+ at the BMS Cell Therapy manufacturing facility in Bothell, WA and will directly report into the Site Head. This role is accountable for the technical support of a multiproduct clinical and commercial GMP autologous CAR-T drug product manufacturing site, including process, facility and equipment validation, manufacturing process support (e.g., investigations, deviations, change controls, CAPAS), automation and MES, plus identifying and implementing policies, procedures and manufacturing strategies to facilitate optimal and compliant production / process and performance.
As a member of the site leadership team, this position will be responsible for helping set strategic direction for the site, including leadership of process improvement activity, capacity increases and introduction of the clinical pipeline into the site to deliver on pivotal and commercial launch responsibilities. The ideal candidate will have a track record of talent management, nurturing and driving a culture of collaboration, continuous improvement and alignment between various functions and departments on site and across the network, to ensure that major site & business strategic manufacturing objectives are met. In particular the role requires close partnership with Global Technical Operations and the broader BMS community to transfer, implement, validate, file, and license new products/processes and maintain existing products/processes.
This person is a key leader at the site and has significant responsibility for delivering on critical business expectations, including technical transfer and project milestones and managing a department that will have a direct impact on the growth and success of the BMS cell therapy franchise and its impact on our patients. This role is ideal for a 'people first' technical leader, who sees their success through guiding and developing their team to deliver on commitments for the site and broader cell therapy network. Experience in process development, clinical and commercial manufacturing is preferred due to the nature of the BMS cell therapy portfolio and the site's responsibility for pivotal clinical and commercial launch activity.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education:
Leadership & People Management:
The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decid ed based on demonstrated experience.
For more on benefits, please visit our BMS Careers si te.
Eligibility for specific benefits listed in our careers site may vary based on the job and location.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
WORKING CONDITIONS (US Only):
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.
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/ 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.
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:
This role leads the Manufacturing Science and Technology (MSAT) team of 50+ at the BMS Cell Therapy manufacturing facility in Bothell, WA and will directly report into the Site Head. This role is accountable for the technical support of a multiproduct clinical and commercial GMP autologous CAR-T drug product manufacturing site, including process, facility and equipment validation, manufacturing process support (e.g., investigations, deviations, change controls, CAPAS), automation and MES, plus identifying and implementing policies, procedures and manufacturing strategies to facilitate optimal and compliant production / process and performance.
As a member of the site leadership team, this position will be responsible for helping set strategic direction for the site, including leadership of process improvement activity, capacity increases and introduction of the clinical pipeline into the site to deliver on pivotal and commercial launch responsibilities. The ideal candidate will have a track record of talent management, nurturing and driving a culture of collaboration, continuous improvement and alignment between various functions and departments on site and across the network, to ensure that major site & business strategic manufacturing objectives are met. In particular the role requires close partnership with Global Technical Operations and the broader BMS community to transfer, implement, validate, file, and license new products/processes and maintain existing products/processes.
This person is a key leader at the site and has significant responsibility for delivering on critical business expectations, including technical transfer and project milestones and managing a department that will have a direct impact on the growth and success of the BMS cell therapy franchise and its impact on our patients. This role is ideal for a 'people first' technical leader, who sees their success through guiding and developing their team to deliver on commitments for the site and broader cell therapy network. Experience in process development, clinical and commercial manufacturing is preferred due to the nature of the BMS cell therapy portfolio and the site's responsibility for pivotal clinical and commercial launch activity.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education:
- Bachelor's Degree required (science or engineering). Graduate or higher-level Degree is preferred.
- Minimally 15+ years of biotech, cell therapy, pharmaceutical or medical device industry experience in process development, process scale up/manufacturing and process validation.
- 8 or more years ' people management experience
- Experience with commercial scale manufacturing support for mammalian cell culture, aseptic final product filling/kitting/ labeling, liquid media manufacturing (vials, bags, bottles) and/or analytical reagent (e.g. endotoxin detection assay) manufacture, current Good Manufacturing Practices, US/EU regulations, and supervision.
- In depth knowledge of large scale biologic, pharmaceutical or medical device manufacturing, current Good Manufacturing Practices (cGMP) and US/EU regulations and intermediate knowledge of statistical data analysis.
- Knowledge should include a combination of cell biology, cell culture, and aseptic processing technologies and include small scale (laboratory) experience.
Leadership & People Management:
- Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.
- Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
- Establish strategic goals and objectives and maintain full strategic responsibility for the MSAT organization.
- As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
- Accountable for overall budget and financial performance of the MSAT organization.
- Proactively promote positive Safety Culture and cGMP operating principles.
- Ensure Right to Operate through compliance with cGMP and regulatory requirements applicable to the department.
- Validation: Own, execute and improve the validation program for equipment, utilities, facility, APS, EMPQ, and ensure compliance with quality system and health authority requirements. Represent Validation program during health authority inspections.
- Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with the quality system and health authority requirements. Represent Automation program during health authority inspections.
- Technical Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes.
- Manufacturing Support: Provide technical support to manufacturing organization including process and product monitoring, compliance to quality systems, and other readiness operational support activities. Respond to and proactively identify issues, determine root cause, and solve forever. Develop, prioritize and drive continuous improvements and other readiness operational maintenance activities that reduce safety risks, operational costs, lead times, and scrap/discrepancy rates across all aspects of production.
The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decid ed based on demonstrated experience.
For more on benefits, please visit our BMS Careers si te.
Eligibility for specific benefits listed in our careers site may vary based on the job and location.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
WORKING CONDITIONS (US Only):
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.
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/ 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.