Bristol-Myers Squibb
Associate Director, Cleanroom Operations
Bristol-Myers Squibb, Summit, New Jersey, us, 07902
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, Cleanroom Operations
, leads a team of Senior Managers, Managers, Team Leads and Material Handlers that interface with GMP cleaning and EM sampling partners responsible for all processes associated with GMP cleaning & EM Sampling within CAR T clinical and commercial operations in a several cGMP multi-cleanroom suite as well as control/enhancement of CNC/Cleanroom/Transitional areas part of production.
This position plays a critical role in the CAR T production processes ensuring appropriate controls, complete traceability, and efficient operations regarding effective cleaning processes of GMP areas and cleanrooms (CNC, Classified Areas), along with EM sampling of these areas.
The AD leads GMP Cleaning/EM Sampling teams and other cleanroom partners across several production areas and multiple shifts (future 12hr/7d Operation). This position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and applicable policies, regulations and certifications including training, documentation, standard operating procedures, and corporate policies, while maintaining a culture of safety, compliance, innovation, and Continuous Improvement.
Shifts Available:
Monday - Friday, Standard Working Hours
Responsibilities:
Accountable for completion of production tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Responsible for role modeling and driving safety, accountability and sustainable processes within the team and respective team members. Perform regular safety Gemba walks, identify the hazards associated with team's work and provide process-based solutions for safety challenges.
Accountable for the Production Records/Process Documentation produced by the team. Execute/perform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced by the team follows the ALCOA+ principles.
Perform Cell Therapy production steps to maintain hands-on expert knowledge of each Unit Operation, role model good execution and behaviors for team members and if necessary, able to backfill execution resources to meet the production schedule.
Responsible for providing the Production Scheduling team with information (daily, weekly monthly) on the availability production resources and task execution/progression.
Actively set team priorities and adjust as necessary to align with site and or functional priorities, establishes the team goals and monitor, measure and assess the performance/completion of the team production activities and goals. Report performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.
Drive completion, adherence to training requirements and assess appropriate level of training for team members, complete training plan on time and ensure proficiency and qualification to perform the production tasks. Monitor team training due dates and maintain the trained status of all team members by ensuring appropriate time is allocated to training activities.
Support and build a high performing team of Operators and Supervisors, including help recruiting exceptional people, conducting interviews/reviews candidate suitability, and providing meaningful feedback to current and future employees/leadership, Talent Acquisition and HR partners. Build a culture of ethics and decision making.
Responsible for creating/managing Workday profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous feedback to improve performance and ensure behavior not aligned with the BMS values.
Conduct regular 1:1 meetings with team members to mentor, develop/motivate individuals, and enable team members with their professional development.
Lead troubleshooting activities for the team and provide ownership of Deviations occurring in area, capture the relevant background and potential causal factor information in a timely fashion. Author clear, concise and factually complete description of events that led to the deviation and enter the deviation record information in the system. Report deviation progress, help maintain proper deviation metrics, identify repeat causes of deviations and closes out all deviations on time.
Build trust and productive relationships with peers and stakeholders, while driving collaboration across the company and external partners.
Participate in projects, change controls and CAPAs as required to restore area performance and ensure optimal compliance levels. Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources to resolve. Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability.
Effectively control expenses within their influence (OT, Supplies, T&E).
Lead by example, role model leadership behaviors and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion.
Knowledge & Skills:
Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications
Advanced knowledge of microbiology and best cleaning practices including best industry practices, application of principles, concepts, practices, standards, validation, and qualification
Strong knowledge and application of OSHA, DEA, USP and other applicable WH regulations
Proficiency in ERP systems / WMS Applications and analytics tools
Proficiency in system and application use for business operations
Proficiency in MS Office applications
Proficiency in analytical, problem-solving, critical thinking skills and strong situational decision making
Proficient organizational and time management skills
Strong written and verbal communication skills
Intermediate presentation development and delivery skills
Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements
Ability to travel 5% - 10% of time
Personal responsibility to work safely and ensure colleagues do the same
Champion for continuous improvement activities
Develop a deep ownership and understanding of one's work area
Establish performance measures and targets to drive improvements
Participate in reviews of performance, generate improvement ideas and take action
Use of visual management so no problem is hidden
Lead daily Tier 1 meetings
Build a culture of finding root causes and actions to prevent reoccurrence
Increase right-first-time performance by adhering to GMP documents and procedures, proactively prevent deviations, identify root causes, and take preventative actions
Become a high performing organization through a commitment to learning and improvement
Learn from successes and failures and share knowledge across the VS teams
Become the expert of your area and capture knowledge so all team members can benefit
Use of Lean principles to remove non-value-added activities to improve operational efficiency
Application of Lean tools to reduce waste and remove variability in processes
Use actual results to identify waste, reduce variation and improve productivity
Maintain balanced and unbiased functional relationships, champion a culture of exceptional teamwork and communication across the organization
Identify and mitigate risks in production operations that could negatively impact delivery of safe and effective therapies to patients
Basic Requirements:
Bachelor's degree in supply chain, engineering, life sciences, information systems, business management or related fields
9+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment
7+ years' experience in manufacturing and supply chain areas
8+ years direct supervisor / personal management experience
Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
An equivalent combination of education, experience and training may substitute
Working Conditions:
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary
Physical dexterity to effectively use computers and documentation
Vision and hearing capability to work in job environment
Lift maximum of 25 pounds
Ability to work around laboratories and controlled, enclosed, restricted areas
Wear required cleanroom garments and personal protective equipment including PAPRs
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas
Exposure to reagents, chemicals, exposure to sanitization agents are expected, and potential exposure to human blood components
Areas may prohibit food, any outside materials, cell phones, and tablets
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:
R1585850
Updated:
2024-11-13 03:12:22.253 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, Cleanroom Operations
, leads a team of Senior Managers, Managers, Team Leads and Material Handlers that interface with GMP cleaning and EM sampling partners responsible for all processes associated with GMP cleaning & EM Sampling within CAR T clinical and commercial operations in a several cGMP multi-cleanroom suite as well as control/enhancement of CNC/Cleanroom/Transitional areas part of production.
This position plays a critical role in the CAR T production processes ensuring appropriate controls, complete traceability, and efficient operations regarding effective cleaning processes of GMP areas and cleanrooms (CNC, Classified Areas), along with EM sampling of these areas.
The AD leads GMP Cleaning/EM Sampling teams and other cleanroom partners across several production areas and multiple shifts (future 12hr/7d Operation). This position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and applicable policies, regulations and certifications including training, documentation, standard operating procedures, and corporate policies, while maintaining a culture of safety, compliance, innovation, and Continuous Improvement.
Shifts Available:
Monday - Friday, Standard Working Hours
Responsibilities:
Accountable for completion of production tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Responsible for role modeling and driving safety, accountability and sustainable processes within the team and respective team members. Perform regular safety Gemba walks, identify the hazards associated with team's work and provide process-based solutions for safety challenges.
Accountable for the Production Records/Process Documentation produced by the team. Execute/perform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced by the team follows the ALCOA+ principles.
Perform Cell Therapy production steps to maintain hands-on expert knowledge of each Unit Operation, role model good execution and behaviors for team members and if necessary, able to backfill execution resources to meet the production schedule.
Responsible for providing the Production Scheduling team with information (daily, weekly monthly) on the availability production resources and task execution/progression.
Actively set team priorities and adjust as necessary to align with site and or functional priorities, establishes the team goals and monitor, measure and assess the performance/completion of the team production activities and goals. Report performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.
Drive completion, adherence to training requirements and assess appropriate level of training for team members, complete training plan on time and ensure proficiency and qualification to perform the production tasks. Monitor team training due dates and maintain the trained status of all team members by ensuring appropriate time is allocated to training activities.
Support and build a high performing team of Operators and Supervisors, including help recruiting exceptional people, conducting interviews/reviews candidate suitability, and providing meaningful feedback to current and future employees/leadership, Talent Acquisition and HR partners. Build a culture of ethics and decision making.
Responsible for creating/managing Workday profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous feedback to improve performance and ensure behavior not aligned with the BMS values.
Conduct regular 1:1 meetings with team members to mentor, develop/motivate individuals, and enable team members with their professional development.
Lead troubleshooting activities for the team and provide ownership of Deviations occurring in area, capture the relevant background and potential causal factor information in a timely fashion. Author clear, concise and factually complete description of events that led to the deviation and enter the deviation record information in the system. Report deviation progress, help maintain proper deviation metrics, identify repeat causes of deviations and closes out all deviations on time.
Build trust and productive relationships with peers and stakeholders, while driving collaboration across the company and external partners.
Participate in projects, change controls and CAPAs as required to restore area performance and ensure optimal compliance levels. Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources to resolve. Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability.
Effectively control expenses within their influence (OT, Supplies, T&E).
Lead by example, role model leadership behaviors and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion.
Knowledge & Skills:
Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications
Advanced knowledge of microbiology and best cleaning practices including best industry practices, application of principles, concepts, practices, standards, validation, and qualification
Strong knowledge and application of OSHA, DEA, USP and other applicable WH regulations
Proficiency in ERP systems / WMS Applications and analytics tools
Proficiency in system and application use for business operations
Proficiency in MS Office applications
Proficiency in analytical, problem-solving, critical thinking skills and strong situational decision making
Proficient organizational and time management skills
Strong written and verbal communication skills
Intermediate presentation development and delivery skills
Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements
Ability to travel 5% - 10% of time
Personal responsibility to work safely and ensure colleagues do the same
Champion for continuous improvement activities
Develop a deep ownership and understanding of one's work area
Establish performance measures and targets to drive improvements
Participate in reviews of performance, generate improvement ideas and take action
Use of visual management so no problem is hidden
Lead daily Tier 1 meetings
Build a culture of finding root causes and actions to prevent reoccurrence
Increase right-first-time performance by adhering to GMP documents and procedures, proactively prevent deviations, identify root causes, and take preventative actions
Become a high performing organization through a commitment to learning and improvement
Learn from successes and failures and share knowledge across the VS teams
Become the expert of your area and capture knowledge so all team members can benefit
Use of Lean principles to remove non-value-added activities to improve operational efficiency
Application of Lean tools to reduce waste and remove variability in processes
Use actual results to identify waste, reduce variation and improve productivity
Maintain balanced and unbiased functional relationships, champion a culture of exceptional teamwork and communication across the organization
Identify and mitigate risks in production operations that could negatively impact delivery of safe and effective therapies to patients
Basic Requirements:
Bachelor's degree in supply chain, engineering, life sciences, information systems, business management or related fields
9+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment
7+ years' experience in manufacturing and supply chain areas
8+ years direct supervisor / personal management experience
Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
An equivalent combination of education, experience and training may substitute
Working Conditions:
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary
Physical dexterity to effectively use computers and documentation
Vision and hearing capability to work in job environment
Lift maximum of 25 pounds
Ability to work around laboratories and controlled, enclosed, restricted areas
Wear required cleanroom garments and personal protective equipment including PAPRs
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas
Exposure to reagents, chemicals, exposure to sanitization agents are expected, and potential exposure to human blood components
Areas may prohibit food, any outside materials, cell phones, and tablets
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:
R1585850
Updated:
2024-11-13 03:12:22.253 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.