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Head, CAR-T Manufacturing Operations

Req #: 1700500
Location: Summit, NJ US
Job Category: Manufacturing/Technical Operations
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit West

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The Head CAR-T Manufacturing leads a cross-functional team responsible for production of personalized cell therapy products that support both global clinical trials and commercial supply.  Manages all internal manufacturing activities including cell isolation, cell engineering, cell culture, drug product formulation/filling, media/buffer preparation, and packaging/cold chain operations.  Develops and executes a manufacturing plan that matches the needs of the clinical programs and commercial market demand to ensure timely, efficient, and cost effective delivery of quality products.

Responsibilities include, but are not limited to, the following:

  • Ensure safe and compliant cGMP operations
  • Maintain permanent inspection readiness and actively support regulatory inspections
  • Optimize the organizational structure to maximize productivity and communication flow
  • Develop productivity and financial goals with the cross-functional team
  • Implement metrics to track and manage completion of objectives and projects
  • Allocate resources to ensure supply plans are met within the planned schedule and budget
  • Partner with the Facilities and Technical support functions to monitor the condition of manufacturing equipment, facilities, and infrastructure. Act as area owner and identify/arrange any necessary maintenance or work orders.
  • Ensure staff are appropriately trained and qualified for the activities they perform
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements
  • Prepare and maintain the overall budget for the manufacturing organization
  • Provide technology transfer, validation, and manufacturing support
  • Monitor plant performance metrics and lead plant operating review meetings

Leadership:

  • Create an environment of teamwork, open communication, and sense of urgency
  • Lead as a change agent to promote flexibility, creativity, and accountability
  • Establish clear strategic goals and objectives for the organization that are linked to the overall company strategy
  • Drive strong collaboration within the plant and across the network
  • Build trust and effective relationships with peers and stakeholders
  • Deliver business results through timely and quality decision making and advice
  • Foster a culture of compliance and strong environmental, health, and safety performance
  • Promote a mindset of continuous improvement, problem solving, and prevention

Skills/Knowledge Required:

  • Expert knowledge of cGMP’s and multi-national pharmaceutical regulations
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Hands-on experience with single use technologies, closed systems, and cold chain technologies
  • Experience working with external parties and/or leading cross-functional teams
  • Project management experience leading multi-functional and multi-location teams
  • Possess strong verbal/written communication skills and ability to influence at all levels
  • Ability to think strategically and to translate strategy into actions
  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment
  • Experience with Operational Excellence and Lean Manufacturing
  • Bachelor’s Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred
  • 15 or more years of work experience in the pharmaceutical or related industry
  • 8-10 or more years of people management experience
  • 10 or more years of manufacturing/production or related experience in the pharmaceutical industry

#LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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