Manager, Opex CAR T

Celgene Corporation in Warren, NJ

  • Type: Full Time
position filled

Organization:

Business Operations
Employee Status:
Job Type: Regular

Position Summary


The Mgr/Sr. Manager CAR-T Operational Excellence is responsible for leading the development and execution of site continuous improvement initiatives to meet the business objectives as identified by the site leadership team. He/She collaborates with SMEs from Manufacturing, Manufacturing Sciences Support, Supply Chain, Warehouse, and Quality Groups while planning, managing and coordinating OpEx activities in support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Responsibilities include, but are not limited to, the following:
  • Ensure safe and compliant cGMP operations.
  • Learn the procedures, analytics and documentation.
  • Lead the development and execution of process improvement initiatives. 
  • Manage, update and report the Department Scorecard metrics, aligned with the Site Balanced Scorecard. Support and mentor front-line teams in the understanding and improvement of Key Performance Indicators.
  • Work closely with Process Engineering and Support on the design and implementation of new technology and new systems/facilities related to production process needs.
  • Interact with other teams including Development, Operations, QA and Regulatory. Provide guidance on process capability, manufacturing capacity, loss reductions and Key Performance Indicator improvement.
  • Drive team-based and data-driven culture among all levels of site personnel to increase efficiency and involvement.
  • Assist site leadership in the expansion and implementation of root cause and investigative tools and LEAN based continuous improvement.
  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
  • Foster strong inter-team relationships to achieve common project goals.
  • Support Sr. Director in accomplishing productivity and financial goals with the cross-functional team.
  • Support the tracking of team metrics and manage completion of objectives and projects.
  • Participate in routine plant operating meetings.

  • Leadership:
  • Create an environment of teamwork, open communication, and a sense of urgency
  • Support the change agent in promoting flexibility, creativity, and accountability
  • Support organizational strategic goals and objectives 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 :
  • Bachelor’s Degree required (science or engineering, advance degree is preferred)
  • Lean Six Sigma Black Belt Certification
  • 10 or more years of manufacturing support or related experience in the biopharmaceutical industry
  • 3 or more years of people management experience required
  • 3 or more years of lean manufacturing environment experience required
  • Expert knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations
  • Deep knowledge of facility/clean room design, process, equipment, automation, and validation
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
  • Experience working with external parties and/or leading cross-functional 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


  • About Us

    COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

    At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

    "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

    There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

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