Bristol Myers Squibb Company

Supervisor, Quality Control Microbiology (Wednesday-Saturday) 2nd Shift Cell Therapy

Location
Summit West, NJ, United States
Posted
Aug 26, 2020
Ref
R1529087
Required Education
Bachelors Degree
Position Type
Full time
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

The Supervisor, QC Microbiology 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 non-routine microbiological testing and activities (Aseptic Process Simulations, Environmental Monitoring Performance Qualification, Gowning Qualification, Contamination Control activities) in support of CAR T manufacturing operations. Trends data, prepare metrics, reviews documents, trains personnel, writes procedures, protocols/reports, performs investigations and works on CAPAs. 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, federal and local laws and ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory guidelines/requirements at all times. This is a Wednesday Saturday position with working hours 1:00pm-11:30PM.

Required Competencies: Knowledge, Skills, and Abilities

• Ability to interact with regulatory agencies 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/requirements.

• Ability to interpret and write complex 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 skills, 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 problems.

• Ability to gown and maintain an aseptic work environment.

- 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 equipment.
  • 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 cross-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 required.
  • 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

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.

. This position may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb).

• This may also include concentrating, 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.

• Will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.

BMSCART

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.