Specialist, Environmental Monitoring Team Lead

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. 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.

This position will report to the Manager of MSS-EM. The Lead will work with a team of MSS-EM Samplers to ensure that routine/non-routine Environmental Monitoring (EM Sampling) in the GMP areas of Summit West CAR-T Manufacturing and Warehouses areas is performed. The MSS-EM Lead will provide oversight for collection of environmental monitoring samples for the controlled, non-classified areas as well as controlled non-aseptic and aseptic processing areas of manufacturing.

Shift Available:

• Sunday - Thursday, Onsite Morning Shift, 4 a.m. - 12 p.m.

Responsibilities:

• Accountable to ensure completion of EM Monitoring Sampling 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.
• Lead and ensure EM sampling responsibilities are performed in accordance with the organization’s policies, procedures, state, federal and local laws.
• Drive compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
• 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 maintain the trained status of all team members by ensuring appropriate time is allocated to training activities.
• Lead will collaborate with Supply Chain Scheduling, Abecma, Breyanzi, Media Prep and Warehouse Ops Management to ensure timely and accurate EM sampling of GMP areas.
• Scheduling EM Sampling for routine EM every week for the team.
• Lead will serve as the liaison to the QC teams for testing of EM samples.
• Communicate effectively with Manufacturing Operations peers, cross-functional peers and management.
• Assist in troubleshooting and solving problems with various functional groups to drive efficiency and productivity.
• Lead EM Sampling Team to perform Environmental Monitoring on a routine and non-routine basis under Static and Dynamic conditions for all S12/S16 and S6A GMP manufacturing and associated warehouse areas.
• Responsible to be the Point of Contact and Communication with Facilities and other functional groups during planned or unplanned events like Air Reversals to be able to pull together the team to perform EM Sampling for Suite Release. Under the guidance of management, support special project work and continuous improvement initiatives for MO.
• Perform Environmental Monitoring Sampling 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.
• 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.
• Lead troubleshooting activities for the team and provide ownership of Deviations occurring in area and Support and/or lead investigations & CAPAs associated with EM excursions Build trust and productive relationships with peers and stakeholders while driving collaboration across the company and external partners.
• 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:

• Expertise in Environmental Monitoring in aseptic and non-aseptic processing areas.
• Ability to stand for extended periods of time.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, face, core body, arms/hands, and legs/feet.
• Position requires the ability to wear aseptic gowning (ISO7/ISO8).
• Must have strong technical writing capability to support deviation investigations, change control evaluations, and closure of CAPAs.
• Ability to support on-boarding and training of new EM associates.
• Ability to become gown qualified and perform EM duties within the warehouse, media, and cell processing suites.
• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
• Strong knowledge and application of OSHA, DEA, USP and other applicable WH regulations.
• Proficiency in systems like CELabs, CMMS 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 and Strong written and verbal communication skills.
• Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements.
• Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrates ability to follow detailed directions in a manufacturing cGMP environment.
• Reliable with ability to respond to challenges in a positive, and objective manner.
• Adaptable to dynamic conditions, work practices, and schedules.
• Able to communicate effectively with cross-functional areas and external agencies.

Basic Requirements:

• Requires a High School diploma or equivalent. Associate or bachelor’s degree in a scientific discipline preferred.
• 3 years demonstrated work experience in a cGMP environment.
• 1 year of leadership experience required.
• Strong MS Office skills.
• Strong understanding of GMP practices.

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.

Compensation Overview:

Summit West - NJ - US: $38.12 - $46.20per hour


The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.

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.

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 a supportive culture, promoting global participation 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 an 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.

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/

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