Supervisor Quality Control Microbiology and Environmental Monitoring Wednesday - Saturday - Second Shift Cell Therapy

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Purpose and Scope of Position

The Supervisor, Quality Control Microbiolog y and Environmental Monitoring supervises and oversees the activities and personnel in the microbiology group as they perform routine (Environmental Monitoring, Sterility, Growth Promotion, EM plate reads, Microbial Identifications, Endotoxin, Mycoplasma, Sterility, Growth Promotion, EM plate reads, etc.) and no n- routine mi crobiological testing and activities (Aseptic Process Simulations, Environmental Monitoring Performance Qualification, Gowning Qualification, Contamination Control activities) in support of CAR T manufacturing operations. T rends data, prepare metrics, reviews documents, trains personnel , write s procedures , protocols/reports, performs investigations and works on CAPA s . Supervisor may be required to be hands on and perform lab tasks/testing as needed. The Supervisor performs responsibilities independently in accordance with the BMS's policies, procedures, and state, fed e ral and local laws and ensure com pliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory guidelines/ requirements at all times.

Required Competencies: Knowledge, Skills, and Abilities

Ability to interact with regulato r y agencie s and internal auditors .

Flexibility with working hours, ability to multi-task and work well under tight timelines.

Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory guidelines/ requirement s .

Ability to interpret and wr it e comple x documents .

Advanced written, verbal, and interpersonal communication skills.

Advanced knowledge/experience with MS Word, Outlook, Excel, MS PowerPoint, Visio, LIMS.

Advanced understanding of data integrity and good documentation practices.

Strong problem - solving, troubleshooting skill s, critical reasoning and decision-making skills .

Strong organization and time management skills.

Strong team spirit, work ethics and accountability.

Able to develop and motivate others; delegate and solve routine problem s .

Ability to gown and maintain an aseptic work environmen t .- Ability to prioritize well and escalate matters through proper chain of commands.

Ability to be flexible related days of work and hours of work to support the business needs. Duties and Responsibilities

Train and mentor lab personnel as needed.

Ensure employees assigned to lab and EM tasks are properly trained.

Complete performance evaluations, take disciplinary actions as needed and support career development of direct reports as needed.

Foster positive and inclusive work environment.

Oversee personnel work schedule to ensure all assigned tasks are performed in a timely manner.

Perform testing/lab activities when needed.

Check and maintain lab inventory as needed.

Support periodic maintenance of the lab equipments.

Ensure labs are always in audit ready state.

Write and review investigational test plans and reports as needed.

Write, review and approve Environmental Monitoring Performance Qualification, Gowning Qualification, Contamination Control activities.

Write and review investigational test plans and reports as needed.

Utilize scientific principles to assist in troubleshooting and problem solving for deviations.

Plans, develops and works on special project work as needed.

Initiates, writes and performs Investigations/CAPAs associated with microbiological testing.

Serve as author and/or technical reviewer of departmental SOPs and other technical documents.

Write and review protocols and reports.

Review EM data, release test data and any other Microbiology lab data/logbooks.

Effectively communicates with department and cros s- functional management.

Participate in cross-function meetings as needed.

Perform other duties as assigned. Education and Experience

Bachelor's degree required, preferably in Microbiology or related science.

7-10 years' relevant work experience required, preferably in a Microbiology and Environmental Monitoring group in a Pharmaceutical manufacturing environment with cGMP requirements.

Experience with Environmental Monitoring, Sterility, Growth Promotion, EM plate reads, Microbial Identifications etc. is required.

Experience with cell therapy products is preferred.

People management and big team experience preferred.

Extensive testing experience is required since this will be a hands-on/lab-based role.

Knowledge of qPCR Assays is required.

Experience with Aseptic Process Simulations, Environmental Monitoring Performance Qualification, Gowning Qualification, Contamination Control activities.

An equivalent combination of experience/education is acceptable. Working Conditions Work hours would be 10 hour shifts (Wednesday-Saturday from 1:00PM-11:30PM). Must be flexible as hours and days of the week may change based on business needs. Available to work holidays, weekends as well as being available off hours is an absolute must. Training will be on first shift until transitioned to second shift. . This position may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb).

Thi s ma y als o includ e conc entrating, effective verbal and/or written communication, analytical thinking, working under tight timelines, decision making, and adapting to change.

This position involves working conditions with constricted personnel movements for up to two (2) hours a day.

This position could require working within controlled environments with defined gowning requirements.

This position requires working around magnetic fields and radio frequencies.

Wil l be required t o wea r uniform / PP E to wor k i n a m anufacturing, warehouse, or laborato r y environment.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 the resources to pursue their goals, both at work and in their personal lives. Company: Bristol-Myers Squibb Req Number: R1520833_EN Updated: 2020-01-28 00:00:00.000 UTC Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com