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Clinical Manufacturing Supervisor, Cell Therapy

Company: Bristol Myers Squibb
Location: Warren
Posted on: June 4, 2021

Job Description:

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:

Provide supervision for a team of employees who manufacture human blood derived components per Standard Operating Procedures (SOPs) and Master Batch Records (MBR's) in a controlled, cleanroom environment of a multi-product clinical facility. Manufacturing Supervisors address employee concerns, ensures staff are complaint with training requirements, reviews & approves timecards, and addresses production issues with cross functional teams. Manufacturing supervisors are expected to manage technical and personnel needs for transfers into and out of facility. Communication of production deviations and assistance with quality investigations are required, as applicable.

Duties and Responsibilities:

  • Ensure staff are properly trained on controlled, approved GMP procedures.
  • Become trained on all aspects of assigned processes
  • Manage tech transfers into and out of facility
  • Develop a high level of technical knowledge of project(s)
  • Manage all administrative items for direct reports.
  • Document employee growth and performance.
  • Document and address employee corrective actions and performance improvement plans.
  • Pre- and Post-Production shift communication to manufacturing team.
  • Manage cross functionally to resolve on the floor production concerns
  • Escalate concerns/ issues to Manufacturing Management.
  • Interview potential new employees.
  • Perform additional duties as assigned and necessary.
  • Interact and communicate with supporting departments and representatives

Required Competencies:

Knowledge/ Skills, and Abilities:

  • Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
  • Experience within cGMP/FDA regulated industry
  • Basic mathematical skills
  • Technical writing capability
  • Proficient in MS Office applications
  • Previous experience managing, coaching, and providing instructions to staff
  • Preferred- experience with electronic inventory systems (Oracle, etc)

Education and Experience:

  • Masters degree in a scientific discipline plus 4 years of relevant experience OR Bachelor's degree in a scientific discipline plus 6 years of relevant experience

Working Conditions:

  • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
  • Flexible hours may be required to meet manufacturing needs
  • Physical dexterity sufficient to use computers and documentation.
  • Sufficient vision and hearing capability to work in job environment.
  • Ability to lift up to 25 pounds.
  • Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
  • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
  • 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. Reagents, chemicals, and exposure to sanitization agents are expected.
  • Routine exposure to human blood components.
  • Designated areas prohibits food, any outside materials such as cell phones, tablets, at a minimum.
  • Potential 5% domestic travel

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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Keywords: Bristol Myers Squibb, Elizabeth , Clinical Manufacturing Supervisor, Cell Therapy, Other , Warren, New Jersey

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