Associate Director, Equipment Commissioning and Qualification - 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 .
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.
The Associate Director, Equipment Commissioning & Qualification Delivery supports the successful operation of facility, laboratory and manufacturing functions at a commercial cell therapy site through interaction with internal team members and peer-level customers as well as external service providers. The incumbent in this role supervises entry, junior, and experienced level professionals tasked with commissioning and qualifying new equipment, facilities, utilities and maintaining systems in a qualified / validated state according to established policies and procedures. The individual oversees multiple projects and ongoing work activities of low to high complexity to ensure on time and within budget completion. With expert knowledge of commissioning and qualification the individual will interact with regulatory agents, external and/or internal auditors in compliance audit environment. The individual will advise ECQ personnel within their organization on career development and best practices. As a key player for the organization, this position will closely collaborate with cross-functional stakeholders in a dynamic environment and can act as the backup for peers, managers, or direct reports and will be responsible for leading a commissioning and qualification team of ~20-30 employees, contingent workers and outside services.
Shifts Available:
Monday - Friday, Standard Working Hours
Responsibilities:
Direct and manage the CAR-T Equipment Commissioning and Qualification (ECQ) Delivery Team in support of the commercial manufacturing in the Summit West CAR-T facility. This includes:
+ Hiring, mentoring, and developing exceptional people, conducting performance reviews, and identifying opportunities for career growth for Senior Managers, Managers, and Engineers
+ Directly supervising 6-9 Senior Managers/Managers/Engineers
+ Championing a culture of exceptional teamwork, accountability, continuous improvement, and communication across the organization and multiple sites within CTO
+ Ensuring staff at all levels have and maintain the appropriate level of training necessary to support CAR T cGMP manufacturing in a multi-product commercial facility. Building effective cross-functional relationships with Manufacturing, Quality, Supply Chain, MS&T, EHS and Facilities
+ Maintain departmental commissioning and qualification procedures and policies. Ensure site and project qualification master plans comply with global policies and regulatory agency requirements
+ Ensure resources performing qualification activities are knowledgeable of and in tune with latest industry regulations and initiatives
+ Provide input and guidance for change strategy, risk assessment, testing and compliance gaps
+ Ensuring a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements
+ Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed
+ Ensure compliance with Site Qualification Master Plan
+ Departmental lead and SME in both internal and regulatory audits
+ Ensuring safe, quality, and compliant operations
+ Establishing goals, tracking and reporting KPIs, and driving continuous improvement through innovation and implementing lean manufacturing initiatives.
+ Ensuring on time closure and effectiveness of deviation investigations, CAPAs, and change controls.
+ Manage staff workload of multiple complex projects and priorities
+ Championing inspection readiness efforts and initiatives for Right First-Time manufacturing
+ Up to 10% travel may be required
Knowledge & Skills:
+ Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices. Direct experience with ex-US Health Authorities (EMA, Health Canada, PDMA) and inspections, preferably for commercial CAR T products.
+ Expert knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
+ Ability to develop, delegate and motivate others including direct and indirect reports
+ Strong financial acumen
+ Solid understanding of scheduling fundamentals, execution and cost control
+ Advanced understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry
+ Strong multi-tasking ability in conjunction with proven managing skills. Ability to effectively manage multiple projects, initiatives, and activities simultaneously. Excels at meeting objective-oriented schedules and timelines. Ability to work effectively in cross-functional teams to deliver results and meet business objectives.
+ Strong written and verbal communication skills
+ Excellent interpersonal skills with experience dealing with a diverse workforce
+ Strong presentation development and delivery skills
+ Strong background in training and compliance with demonstrated ability to influence and negotiate to meet business requirements.
+ Understanding and proficiency of lean manufacturing concepts, such as tiered management, problem solving, level loading, kaizens, coaching, etc.
Basic Requirements:
+ Bachelor's degree in relevant science or engineering discipline required
+ Minimum of 9 years' experience performing/supporting pharmaceutical application validation in a GMP environment
+ Minimum of 9 years' experience managing personnel and/or projects
+ Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions
+ Thorough knowledge of cGMP in the pharmaceutical industry
+ Strong problem solving skills, strong verbal and written communication skills, and the ability to work independently
+ Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
+ Knowledge of Lean Manufacturing principles preferred
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: R1585595
Updated: 2024-09-26 01:59:03.129 UTC
Location: Summit West-NJ
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 .
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.
The Associate Director, Equipment Commissioning & Qualification Delivery supports the successful operation of facility, laboratory and manufacturing functions at a commercial cell therapy site through interaction with internal team members and peer-level customers as well as external service providers. The incumbent in this role supervises entry, junior, and experienced level professionals tasked with commissioning and qualifying new equipment, facilities, utilities and maintaining systems in a qualified / validated state according to established policies and procedures. The individual oversees multiple projects and ongoing work activities of low to high complexity to ensure on time and within budget completion. With expert knowledge of commissioning and qualification the individual will interact with regulatory agents, external and/or internal auditors in compliance audit environment. The individual will advise ECQ personnel within their organization on career development and best practices. As a key player for the organization, this position will closely collaborate with cross-functional stakeholders in a dynamic environment and can act as the backup for peers, managers, or direct reports and will be responsible for leading a commissioning and qualification team of ~20-30 employees, contingent workers and outside services.
Shifts Available:
Monday - Friday, Standard Working Hours
Responsibilities:
Direct and manage the CAR-T Equipment Commissioning and Qualification (ECQ) Delivery Team in support of the commercial manufacturing in the Summit West CAR-T facility. This includes:
+ Hiring, mentoring, and developing exceptional people, conducting performance reviews, and identifying opportunities for career growth for Senior Managers, Managers, and Engineers
+ Directly supervising 6-9 Senior Managers/Managers/Engineers
+ Championing a culture of exceptional teamwork, accountability, continuous improvement, and communication across the organization and multiple sites within CTO
+ Ensuring staff at all levels have and maintain the appropriate level of training necessary to support CAR T cGMP manufacturing in a multi-product commercial facility. Building effective cross-functional relationships with Manufacturing, Quality, Supply Chain, MS&T, EHS and Facilities
+ Maintain departmental commissioning and qualification procedures and policies. Ensure site and project qualification master plans comply with global policies and regulatory agency requirements
+ Ensure resources performing qualification activities are knowledgeable of and in tune with latest industry regulations and initiatives
+ Provide input and guidance for change strategy, risk assessment, testing and compliance gaps
+ Ensuring a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements
+ Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed
+ Ensure compliance with Site Qualification Master Plan
+ Departmental lead and SME in both internal and regulatory audits
+ Ensuring safe, quality, and compliant operations
+ Establishing goals, tracking and reporting KPIs, and driving continuous improvement through innovation and implementing lean manufacturing initiatives.
+ Ensuring on time closure and effectiveness of deviation investigations, CAPAs, and change controls.
+ Manage staff workload of multiple complex projects and priorities
+ Championing inspection readiness efforts and initiatives for Right First-Time manufacturing
+ Up to 10% travel may be required
Knowledge & Skills:
+ Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices. Direct experience with ex-US Health Authorities (EMA, Health Canada, PDMA) and inspections, preferably for commercial CAR T products.
+ Expert knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
+ Ability to develop, delegate and motivate others including direct and indirect reports
+ Strong financial acumen
+ Solid understanding of scheduling fundamentals, execution and cost control
+ Advanced understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry
+ Strong multi-tasking ability in conjunction with proven managing skills. Ability to effectively manage multiple projects, initiatives, and activities simultaneously. Excels at meeting objective-oriented schedules and timelines. Ability to work effectively in cross-functional teams to deliver results and meet business objectives.
+ Strong written and verbal communication skills
+ Excellent interpersonal skills with experience dealing with a diverse workforce
+ Strong presentation development and delivery skills
+ Strong background in training and compliance with demonstrated ability to influence and negotiate to meet business requirements.
+ Understanding and proficiency of lean manufacturing concepts, such as tiered management, problem solving, level loading, kaizens, coaching, etc.
Basic Requirements:
+ Bachelor's degree in relevant science or engineering discipline required
+ Minimum of 9 years' experience performing/supporting pharmaceutical application validation in a GMP environment
+ Minimum of 9 years' experience managing personnel and/or projects
+ Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions
+ Thorough knowledge of cGMP in the pharmaceutical industry
+ Strong problem solving skills, strong verbal and written communication skills, and the ability to work independently
+ Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
+ Knowledge of Lean Manufacturing principles preferred
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: R1585595
Updated: 2024-09-26 01:59:03.129 UTC
Location: Summit West-NJ
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