Sr. Manager / Associate Director, Global Sterility Assurance CTTO - Bristol Myers Squibb
Summit, NJ
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 .
Title: Sr. Manager / Associate Director, Global Sterility Assurance CTTO
Location: Seattle, WA, Devens, MA or Summit, NJ
At Bristol Myers Squibb we are reimagining the future of cell therapy . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
T he Sr Manager/Associate Director - Sterility Assurance, Cell therapy technical Operations reports to the Director, Global Sterility Assurance within the Technical Operations group in the Cell Therapy Development and Operations (CTDO) organization. This role will provide technical oversight to drug product and vector sites as a global SME covering all aspects of sterility assurance for commercial cell therapy products manufactured globally via internal and external manufacturing sites.
This role will serve a Global technical SM E, supporting internal and external manufacturing sites for vector and drug product . The t eam is accountable for implementation of technical standards and strategies relating to sterility assurance, and ensuring sites are aligned in their approach to contamination control.
This role will also cover life cycle management and implementation of new technologies and strategies with respect to sterility assurance providing SME guidance of support to CT manufacturing sites for routine manufacturing and major investigations. " The role will also provide guidance and support for all aspects of regulatory submission, inspections, IR responses process, equipment and supporting elements of manufacturing validation for all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for viral vector and drug product.
This person will also support sterility assurance activities needed during design and build of new manufacturing plants and new product introductions ensuring compliance with the global health authority expectations and global standards .
Key Responsibilities:
+ Lead, develop and implement scientifically sound and fit for purpose sterility assurance standards and procedures based on current regulations, industry trends and best practices for cell therapy.
+ Create, maintain , deploy global cell therapy sterility assurance technical standards via quality system.
+ Promote innovative and efficient approaches to sterility assurance incorporating risk-based elements and considerations unique to cell therapy production.
+ Serve as global consultant for critical deviations in the network relating to contamination or microbiological challenges. "
+ Support CMC authoring for relevant sections related to contamination control and APS .
+ Promote harmonization and best practices for all aspects of contamination control .
+ Develop and provide guidance for contamination response, Microbial hold studies, disinfectant efficacy
+ Uses trend and scientific data to drive risk-based decisions.
+ Drive innovation in sterility assurance for cell therapy supporting the implementation of new technologies and contamination control strategies (filtration, VHP, etc.)
+ Accountable for development and life cycle management of risk assessments, regulatory gap assessment
+ Support new technology , be a force of innovation by leading studies which seek to generate scientific data to support ---- .
+ Support Network, collaborate with site SME's for
+ Technical review for site-level protocol and reports
+ Technical review for CMO documentation
+ Microbial control strategies for new products
+ Oversight of major contamination investigations
+ Tech transfer (startup activities for process and plant )
+ Act as Cell Therapy liaison to BMS Micro center of excellence
+ Participates in external industry groups to gain knowledge of trends , while serving as an ambassador which seeks to establish BMS as the Cell Therapy leader.
+ Facilitate cell therapy harmonization for existing manufacturing sites and adoption of industry best practices.
Qualifications & Experience:
+ B.S/ MS.S /Ph. D in Microbiology , Biology, or Life Science with 8 + years of relevant experience in the biopharmaceutical industry, with direct experience supporting manufacture of parenteral drugs or ATMP s .
+ Ability to lead complex investigations relating to sterility failure, APS failure, and EM trends such as mold recovery.
+ Experience with aseptic technique, environmental monitoring, EMPQ, APS, disinfection, gowning , isolator technology, ster ilization validation, and elements of a CCS.
+ Experience with QRM and various risk assessment tools .
+ E xcellent communication skills and a talent for diplomacy are essential to the success of this role . This role will collaborate cross-functionally across a diverse global network of teams .
+ Innovative; aims to find practical solutions for complex or novel applications while upholding regulatory requirements.
+ Extensive knowledge of applicable global regulatory standards which apply to both ATMPs and sterility assurance. Is in touch with current industry trends and practical interpretation of regulations as they apply to Cell Therapy .
+ Experience with regulatory inspections and CMC
+ Experience with Quality Management System.
+ Some t ravel (including internationally) may be required , up to 20%
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.
The starting compensation for this job at the Sr. Manager level is a range from $119,000 - $149,000 (if based in Summit, NJ), $124,000 - $155,000 (if based in Devens, MA) and $127,000 - $159,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility).
The starting compensation for this job at the Associate Director level is a range from $156,000 - $195,000 (if based in Summit, NJ), $162,000 - $202,000 (if based in Devens, MA) and $166,000 - $208,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS
Career Site.
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.
#LI-Hybrid
BMSCART
VETERAN
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: R1585581
Updated: 2024-09-24 04:46:05.573 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 .
Title: Sr. Manager / Associate Director, Global Sterility Assurance CTTO
Location: Seattle, WA, Devens, MA or Summit, NJ
At Bristol Myers Squibb we are reimagining the future of cell therapy . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
T he Sr Manager/Associate Director - Sterility Assurance, Cell therapy technical Operations reports to the Director, Global Sterility Assurance within the Technical Operations group in the Cell Therapy Development and Operations (CTDO) organization. This role will provide technical oversight to drug product and vector sites as a global SME covering all aspects of sterility assurance for commercial cell therapy products manufactured globally via internal and external manufacturing sites.
This role will serve a Global technical SM E, supporting internal and external manufacturing sites for vector and drug product . The t eam is accountable for implementation of technical standards and strategies relating to sterility assurance, and ensuring sites are aligned in their approach to contamination control.
This role will also cover life cycle management and implementation of new technologies and strategies with respect to sterility assurance providing SME guidance of support to CT manufacturing sites for routine manufacturing and major investigations. " The role will also provide guidance and support for all aspects of regulatory submission, inspections, IR responses process, equipment and supporting elements of manufacturing validation for all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for viral vector and drug product.
This person will also support sterility assurance activities needed during design and build of new manufacturing plants and new product introductions ensuring compliance with the global health authority expectations and global standards .
Key Responsibilities:
+ Lead, develop and implement scientifically sound and fit for purpose sterility assurance standards and procedures based on current regulations, industry trends and best practices for cell therapy.
+ Create, maintain , deploy global cell therapy sterility assurance technical standards via quality system.
+ Promote innovative and efficient approaches to sterility assurance incorporating risk-based elements and considerations unique to cell therapy production.
+ Serve as global consultant for critical deviations in the network relating to contamination or microbiological challenges. "
+ Support CMC authoring for relevant sections related to contamination control and APS .
+ Promote harmonization and best practices for all aspects of contamination control .
+ Develop and provide guidance for contamination response, Microbial hold studies, disinfectant efficacy
+ Uses trend and scientific data to drive risk-based decisions.
+ Drive innovation in sterility assurance for cell therapy supporting the implementation of new technologies and contamination control strategies (filtration, VHP, etc.)
+ Accountable for development and life cycle management of risk assessments, regulatory gap assessment
+ Support new technology , be a force of innovation by leading studies which seek to generate scientific data to support ---- .
+ Support Network, collaborate with site SME's for
+ Technical review for site-level protocol and reports
+ Technical review for CMO documentation
+ Microbial control strategies for new products
+ Oversight of major contamination investigations
+ Tech transfer (startup activities for process and plant )
+ Act as Cell Therapy liaison to BMS Micro center of excellence
+ Participates in external industry groups to gain knowledge of trends , while serving as an ambassador which seeks to establish BMS as the Cell Therapy leader.
+ Facilitate cell therapy harmonization for existing manufacturing sites and adoption of industry best practices.
Qualifications & Experience:
+ B.S/ MS.S /Ph. D in Microbiology , Biology, or Life Science with 8 + years of relevant experience in the biopharmaceutical industry, with direct experience supporting manufacture of parenteral drugs or ATMP s .
+ Ability to lead complex investigations relating to sterility failure, APS failure, and EM trends such as mold recovery.
+ Experience with aseptic technique, environmental monitoring, EMPQ, APS, disinfection, gowning , isolator technology, ster ilization validation, and elements of a CCS.
+ Experience with QRM and various risk assessment tools .
+ E xcellent communication skills and a talent for diplomacy are essential to the success of this role . This role will collaborate cross-functionally across a diverse global network of teams .
+ Innovative; aims to find practical solutions for complex or novel applications while upholding regulatory requirements.
+ Extensive knowledge of applicable global regulatory standards which apply to both ATMPs and sterility assurance. Is in touch with current industry trends and practical interpretation of regulations as they apply to Cell Therapy .
+ Experience with regulatory inspections and CMC
+ Experience with Quality Management System.
+ Some t ravel (including internationally) may be required , up to 20%
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.
The starting compensation for this job at the Sr. Manager level is a range from $119,000 - $149,000 (if based in Summit, NJ), $124,000 - $155,000 (if based in Devens, MA) and $127,000 - $159,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility).
The starting compensation for this job at the Associate Director level is a range from $156,000 - $195,000 (if based in Summit, NJ), $162,000 - $202,000 (if based in Devens, MA) and $166,000 - $208,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS
Career Site.
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.
#LI-Hybrid
BMSCART
VETERAN
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: R1585581
Updated: 2024-09-24 04:46:05.573 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