Bristol Myers Squibb
Specialist, Environmental Monitoring Team Lead
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Specialist, Environmental Monitoring Team Lead
2 days ago Be among the first 25 applicants
Working with us Challenging, meaningful, and life‑changing work awaits at Bristol Myers Squibb. From optimizing production lines to pioneering breakthroughs in cell therapy, you will help transform patients’ lives while growing alongside high‑achieving teams.
We value balance and flexibility, offering competitive benefits, services, and programs that support your goals both at work and in your personal life. BMS is reimagining the future of cell therapy with a best‑in‑industry team and long‑term commitment to unlock the promise of cure for patients.
This position reports to the Manager of MSS‑EM. The Lead will guide a team of MSS‑EM Samplers ensuring routine and non‑routine Environmental Monitoring (EM) Sampling in GMP areas of Summit West CAR‑T manufacturing and warehouses.
Shift Available
Sunday – Thursday, Onsite Morning Shift, 4 a.m. – 12 p.m.
Responsibilities
Ensure completion of EM Monitoring Sampling tasks for Cell Therapy products in support of product Value Stream outputs per cGMP and approved SOPs/WIs.
Maintain personal safety, promote accountability, and lead safety Gemba walks to identify hazards and demonstrate safe behavior.
Lead EM sampling activities in compliance with organizational policies, state/federal/local laws, and global regulatory requirements.
Drive compliance with cGMP, USP, EU, and other standards.
Oversee training plans for team members, ensuring proficiency and qualification for production tasks.
Collaborate with Supply Chain Scheduling, Abecma, Breyanzi, Media Prep, and Warehouse Ops for timely EM sampling.
Schedule routine weekly EM sampling and act as liaison to QC teams for sample testing.
Communicate effectively with Manufacturing Operations peers, cross‑functional peers, and management.
Assist in troubleshooting and solving problems across functional groups to drive efficiency.
Lead the EM Sampling Team in environmental monitoring across all GMP manufacturing and warehouse areas.
Serve as the point of contact for Facilities and other groups during planned/unplanned events (e.g., Air Reversals, Suite Release).
Support special projects and continuous improvement initiatives under management guidance.
Maintain hands‑on expertise of each Unit Operation, model good execution behaviors, and backfill as needed.
Set priorities, align with site/functional goals, and report performance metrics regularly.
Lead troubleshooting for deviations, investigations, and CAPAs associated with EM excursions.
Drive a culture of inclusion, accountability, innovation, urgency, and passion.
Knowledge & Skills
Expertise in Environmental Monitoring in aseptic and non‑aseptic processing areas.
Ability to stand extended periods; must wear aseptic gowning (ISO7/ISO8) and cleanroom garments.
Strong technical writing for deviation investigations, change control, and CAPA closure.
Support onboarding and training of new EM associates; gown qualified for warehouse, media, and cell processing suites.
Advanced knowledge of cGMP/GDP/pharmaceutical regulations and applications.
Strong knowledge of OSHA, DEA, USP, and other WH regulations.
Proficiency in CELabs, CMMS, and MS Office; analytical, problem‑solving, critical thinking skills.
Excellent organizational, time‑management, written and verbal communication.
Adaptability to changing business conditions and regulatory compliance.
Ability to work independently or as part of a team; follow detailed directions in a cGMP environment.
Positive, objective response to challenges; dynamic work practices and schedules.
Basic Requirements
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.
Compensation Overview Summit West – NJ – US $38.12 – $46.20 per hour (full‑time). Additional incentive cash and stock opportunities (based on eligibility) may be available. Final individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits may vary by location. For more on benefits, visit https://careers.bms.com/life-at-bms/.
Equal Employment Opportunity BMS is an equal‑opportunity employer. BMS is committed to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. Visit https://careers.bms.com/eeo-accessibility for the complete Equal Employment Opportunity statement.
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Working with us Challenging, meaningful, and life‑changing work awaits at Bristol Myers Squibb. From optimizing production lines to pioneering breakthroughs in cell therapy, you will help transform patients’ lives while growing alongside high‑achieving teams.
We value balance and flexibility, offering competitive benefits, services, and programs that support your goals both at work and in your personal life. BMS is reimagining the future of cell therapy with a best‑in‑industry team and long‑term commitment to unlock the promise of cure for patients.
This position reports to the Manager of MSS‑EM. The Lead will guide a team of MSS‑EM Samplers ensuring routine and non‑routine Environmental Monitoring (EM) Sampling in GMP areas of Summit West CAR‑T manufacturing and warehouses.
Shift Available
Sunday – Thursday, Onsite Morning Shift, 4 a.m. – 12 p.m.
Responsibilities
Ensure completion of EM Monitoring Sampling tasks for Cell Therapy products in support of product Value Stream outputs per cGMP and approved SOPs/WIs.
Maintain personal safety, promote accountability, and lead safety Gemba walks to identify hazards and demonstrate safe behavior.
Lead EM sampling activities in compliance with organizational policies, state/federal/local laws, and global regulatory requirements.
Drive compliance with cGMP, USP, EU, and other standards.
Oversee training plans for team members, ensuring proficiency and qualification for production tasks.
Collaborate with Supply Chain Scheduling, Abecma, Breyanzi, Media Prep, and Warehouse Ops for timely EM sampling.
Schedule routine weekly EM sampling and act as liaison to QC teams for sample testing.
Communicate effectively with Manufacturing Operations peers, cross‑functional peers, and management.
Assist in troubleshooting and solving problems across functional groups to drive efficiency.
Lead the EM Sampling Team in environmental monitoring across all GMP manufacturing and warehouse areas.
Serve as the point of contact for Facilities and other groups during planned/unplanned events (e.g., Air Reversals, Suite Release).
Support special projects and continuous improvement initiatives under management guidance.
Maintain hands‑on expertise of each Unit Operation, model good execution behaviors, and backfill as needed.
Set priorities, align with site/functional goals, and report performance metrics regularly.
Lead troubleshooting for deviations, investigations, and CAPAs associated with EM excursions.
Drive a culture of inclusion, accountability, innovation, urgency, and passion.
Knowledge & Skills
Expertise in Environmental Monitoring in aseptic and non‑aseptic processing areas.
Ability to stand extended periods; must wear aseptic gowning (ISO7/ISO8) and cleanroom garments.
Strong technical writing for deviation investigations, change control, and CAPA closure.
Support onboarding and training of new EM associates; gown qualified for warehouse, media, and cell processing suites.
Advanced knowledge of cGMP/GDP/pharmaceutical regulations and applications.
Strong knowledge of OSHA, DEA, USP, and other WH regulations.
Proficiency in CELabs, CMMS, and MS Office; analytical, problem‑solving, critical thinking skills.
Excellent organizational, time‑management, written and verbal communication.
Adaptability to changing business conditions and regulatory compliance.
Ability to work independently or as part of a team; follow detailed directions in a cGMP environment.
Positive, objective response to challenges; dynamic work practices and schedules.
Basic Requirements
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.
Compensation Overview Summit West – NJ – US $38.12 – $46.20 per hour (full‑time). Additional incentive cash and stock opportunities (based on eligibility) may be available. Final individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits may vary by location. For more on benefits, visit https://careers.bms.com/life-at-bms/.
Equal Employment Opportunity BMS is an equal‑opportunity employer. BMS is committed to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. Visit https://careers.bms.com/eeo-accessibility for the complete Equal Employment Opportunity statement.
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