Manager, GMP Cleaning
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 inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
PURPOSE AND SCOPE OF POSITION:
The Manager, GMP Cleaning leads a team of Supervisors and interfaces with cleaning partners responsible for all processes associated with GMP cleaning within CAR T clinical and commercial operations in a cGMP multi-cleanroom suite.
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).
The Manager leads GMP Cleaning teams and partners across several production areas and multiple shifts (future 12hr/7d Operation). The 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
The scope of the Patient Materials Operation Manager role:
- Accountable for ensuring 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).
- Take personal responsibility to work safely and drive accountability and process for team members to do the same. Perform regular safety Gemba walks, identify the hazards associated with team’s work and demonstrate safe behavior when operating and maintaining equipment to prevent injuries or incidents. 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. Reports out 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, completes their training plan on time and ensures proficiency and qualification to perform the production tasks. Monitors team training due dates and maintains the trained status of all team members by ensuring appropriate time is allocated to training activities.
- Support building of a high performing team of Operators and Supervisors, helps recruit exceptional people, conducts interviews/reviews candidate suitability, and provides 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.
- Conducts 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 out deviation progress, helps 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- 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
EDUCATION & EXPERIENCE:
- Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields
- 5+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment
- 5+ years’ experience in manufacturing, and supply chain areas
- 2+ 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
- 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 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
- Using Lean principles to remove non-value-added activities to improve operational efficiency
- Apply 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
WORKING CONDITIONS (US Only):
- 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
Why You Should Apply:
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
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.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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.