Environmental Monitoring Team Lead (R1560800-en-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.
PURPOSE AND SCOPE OF POSITION:
This position will report to the Manager of Manufacturing EM. The Team Leads will oversee a team of EM associates within the designated Quads, and work both independently and with the team to perform routine and non-routine Environmental Monitoring in GMP areas of Summit West CAR T Manufacturing and Warehouses. The EM Team 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.
Three Quads are available:
Quad 2: Sun-Tues, alternating Wednesday 4 PM-4:30 AM
Quad 3: Thurs-Sat, alternating Wednesday 6:00 AM -6:30 PM
Quad 4: Thurs-Sat, alternating Wednesday 6:00 AM -6:30 PM
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Good knowledge of Microsoft Word and Excel.
- Familiar with requirements for cGMP manufacturing
- Ability to stand for extended periods of time. Ability to become gown qualified and perform EM duties within the media and cell processing suites.
- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
- Technical writing capability to support deviation investigations, and closure of CAPAs.
- Ability and interest to become a Trainer to support on-boarding of new EM associates
- Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
- Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
- Routine exposure to human blood components. Exposure to strong magnets is likely.
- 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 S12 functional areas and external agencies.
Education and Experience:
- Requires a High School diploma or equivalent. Associate or Bachelor’s degree in a scientific discipline preferred.
- Team Lead or supervisory experience preferred.
- 3-5 years demonstrated work experience in a regulated industry.
DUTIES AND RESPONSIBILITIES:
- Ensure EM sampling responsibilities are performed in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
- Ensure the EM Teams follow directions properly, work cooperatively as an individual contributor and as a team member.
- Team Leads will act as a supervisor when needed and will collaborate with Abecma, Breaynzi, Media Prep and Warehouse Ops teams for collection of EM samples.
- Collaborate with QC teams for delivery of EM samples for testing.
- Communicate effectively with Manufacturing Operations peers, cross-functional peers and management.
- Assist in troubleshooting and solving problems that may come up in the day-to-day operation of the department.
- Perform EM monitoring in aseptic process qualifications, such as aseptic gowning and media fill reads.
- Perform Environmental Monitoring on a routine and non-routine basis for all S12 GMP manufacturing and associated warehouse areas.
- Under the guidance of management, support special project work and continuous improvement initiatives for MO.
- Assist with investigations & CAPAs associated with EM excursions.
- Perform all other duties as assigned.
WORKING CONDITIONS (US Only):
- The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment.
- The incumbent may be required to stand and walk for extended amount of time.
- The incumbent may be required to work hazardous materials.
- Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
- Flexible to work shift structures.
- Change to work timings and assigned tasks may occur at a very short notice to support business needs.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by the management.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and 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.
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 approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.