Location
Summit, NJ, United States
Posted on
Jun 11, 2020
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 primary responsibility of this role is to schedule operations supporting clinical and commercial CAR-T manufacturing at the Summit NJ site. The role will require collaboration across internal and external functions to ensure on-time fulfillment of final product. Ideal candidate will have demonstrated ability to balance competing priorities, participate on project teams, and develop policy/procedures.
Duties and Responsibilities
Maintain detailed site plans for operations including apheresis/PBMC receipt, material kitting, process intermediates, manufacturing, and drug product shipments
Point of contact for the Manufacturing Operations team to provide support, facilitating operational continuity and addressing issues as they arise.
Monitor and report KPI
Work with the functional teams on system implementations and continuous improvement projects.
Collaborate with IT Business Partners in support of modeling and scheduling simulation implementations
Maintain and update site procedures for CAR-T material management functions.
Performs other tasks as assigned.
Required Competencies: Knowledge, Skills, and Abilities
Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
Knowledge of cGMP/Pharmaceutical regulations
Understanding of planning / ERP systems and analytics tools
Experience in MS Office applications
Written and verbal communication skills
Presentation development and delivery skills
Technical writing capability
Ability to work independently for extended periods of time
Ability to work as a team
Ability to develop and provide training on various functions
Ability to solve routine and complex problems
Ability to provide on-call support in case of emergent issues
Ability to travel
Education and Experience (As Applicable)
Bachelor's degree required.
2 years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
1 years of experience supporting ERP systems (preferably Oracle EBS).
An equivalent combination of education, experience and training may substitute.
Working Conditions: (US Only)
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
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 may prohibit food, any outside materials such as cell phones, tablets, at a minimum .
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: R1520396_EN
Updated: 2020-01-21 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.
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