Clinical Manufacturing Supervisor CAR-T

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:

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


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: R1519820_EN

Updated: 2020-05-13 00:00:00.000 UTC

Location: Warren,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.

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