Engineer II, CAR T MSAT
Celgene Corporation
US
16h ago

POSITION

Engineer II, CAR-T Clinical MS&T

SUPERVISOR

Senior Manager CAR-T Clinical MS&T

PREREQUISITES

Minimum of 5 years of experience in biologic / vaccine manufacturing support, tech transfer, and validation

Position Summary

The Senior Engineer Clinical CAR-T Manufacturing Science and Technology support is responsible for supporting the production of personalized cell therapy products for global clinical trials.

Collaborates with SME from the Development Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement 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
  • Be a cell therapy technical expert for equipment and aseptic process
  • Maintain permanent inspection readiness and actively support regulatory inspections
  • Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
  • Continuously anticipate and permanently resolve issues that may arise during production
  • Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
  • Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
  • Sponsor and support the change initiatives and the implementation of process improvement initiatives
  • Work closely with Engineering / Maintenance on the design and implementation of new technology and new systems / facilities related to production process needs
  • Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
  • Interact with other teams including IT, Validation, Development, Operations, QA, QC, Materials Management, Facilities & Engineering, and Regulatory
  • Interface with regulatory authorities as required to support Manufacturing Operations audits
  • Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
  • 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 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 :

  • Expert knowledge of cGMP’s and multi-national biopharmaceutical / cell therapy regulations
  • Deep knowledge of facility / clean room design, process, equipment, automation, and validation
  • 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 / 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
  • Bachelor’s Degree required in Engineering or Related Discipline
  • Minimum of 5 years of experience in biologic / vaccine manufacturing support, tech transfer, and validation
  • 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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