Specialist, Environmental Monitoring Team Lead

Bristol Myers Squibb•Summit, NJ

1d•$38 - $46•Onsite

About The Position

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.

Requirements

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.
Requires a High School diploma or equivalent.
3 years demonstrated work experience in a cGMP environment.
1 year of leadership experience required.
Strong MS Office skills.
Strong understanding of GMP practices.

Nice To Haves

Associate or bachelor’s degree in a scientific discipline preferred.

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.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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