Manager, QC Microbiology

Company: Bristol-Myers Squibb
Location: Summit
Posted on: May 28, 2023

Job Description:

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 rich in diversity. 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 .
The Manager, QC Microbiology, is a highly critical role and is responsible for managing the QC Microbiology Laboratory, which supports the CAR T manufacturing site. This department is responsible for microbiological-related testing of in-process samples, final product testing, critical utilities sampling and testing, Validation and requalification support, incoming component testing, and microbiological identification. Sampling and testing must meet or exceed FDA, MHRA, PMDA, EU, and other governmental regulations or guidelines. The Manager, QC Microbiology is responsible for acting as the SME during regulatory inspections and supports the operations as needed.
Responsibilities

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  Mentor lab personnel as needed.
  
  
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  Ensure employees assigned to tasks are properly trained.
  
  
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  Complete performance evaluations and take additional action as needed.
  
  
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  Support career development of direct reports as needed.
  
  
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  Foster a positive and inclusive work environment.
  
  
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  Oversee personnel's work schedule to ensure all assigned tasks are performedin a timely manner.
  
  
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  Perform data review and additional laboratory activities when needed.
  
  
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  Ensure laboratories remain in an audit-ready state.
  
  
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  Utilize scientific principles to assist in troubleshooting and problem-solving for deviations.
  
  
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  Ensure that Microbiology lab test results that exceed the specification limits are submitted as Deviations in the eQRMS system, investigated, and effective CAPAs are implemented.
  
  
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  Support special projects.
  
  
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  Serve as author and/or technical reviewer of departmental SOPs and other technical documents.
  
  
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  Write and review protocols and reports.
  
  
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  Communicate with the department and cross-functional management.
  
  
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  Perform other duties as assigned.
  
  
  Knowledge, Skills, and Abilities
  
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    Ability to interact with regulatory agencies and internal auditors.
    
    
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    Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU, and other global regulatory guidelines/requirements.
    
    
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    Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
    
    
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    Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc.
    
    
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    Must be team-oriented and demonstrate the ability to work cross-departmentally throughout the manufacturing site.
    
    
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    Ability to interpret and write complex documents.
    
    
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    Advanced written, verbal, and interpersonal communication skills.
    
    
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    Advanced knowledge/experience with MS Word, Outlook, Excel, MS PowerPoint, Visio, LIMS.
    
    
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    Advanced understanding of data integrity and good documentation practices.
    
    
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    Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
    
    
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    Strong problem-solving, troubleshooting skills, critical reasoning, and decision-making skills.
    
    
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    Strong organization and time management skills.
    
    
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    Strong team spirit, work ethic, and accountability.
    
    
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    Demonstrated resource management and planning skills.
    
    
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    Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines.
    
    
    Requirements:
    
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      Bachelor's degree in Science
      
      
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      5+ years of Microbiology work experience
      
      
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      Experience in a pharmaceutical manufacturing environment with cGMP requirements
      
      
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      QC Microbiology/EM experience
      
      
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      An equivalent combination of experience/education is acceptable.
      
      
      Preferred Requirements:
      
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        Bachelor's degree in Microbiology
        
        
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        2 years of leadership experience
        
        
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        Experience leading projects
        
        
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        Cell and gene therapy experience
        
        
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        Experience with Aseptic Process Simulations, EM Performance Qualifications, Equipment Qualifications, Gowning Qualifications, and contamination control activities
        
        
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        Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
        
        
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        Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc.
        
        
        Working Conditions
        
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          The incumbent will be required to work in an office and Microbiology laboratory environment.
          
          
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          This position may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting, or carrying (not more than 25lbs).
          
          
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          This position requires concentrating, analytical thinking, working under tight timelines, decision-making, and adapting to change.
          
          
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          This position may require working within controlled environments with defined gowning requirements.
          
          
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          This position requires working around magnetic fields and radio frequencies.
          
          
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          This position requires additionalgowning/PPE to work in manufacturing, warehouse, and laboratory environments.
          
          
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          The position may be expected to be on call, to support manufacturing issues involving sampling and/or test excursions.
          
          
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          Occasional travel may be required.
          
          
          BMSCART
          #LI-Onsite
          If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
          Uniquely Interesting Work, Life-changing Careers
          With a single vision as inspiring as "Transforming patients' lives through science--- ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
          On-site Protocol
          Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
          BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
          BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
          BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
          Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
          Company: Bristol Myers Squibb
          Req Number: R1568206
          Updated: 2023-05-25 02:04:41.596 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.

Keywords: Bristol-Myers Squibb, New York , Manager, QC Microbiology, Executive , Summit, New York