Celgene Director, CAR-T Process Engineering & Tech Support in Summit, New Jersey

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.

PREREQUISITES

Experience in biologic/vaccine manufacturing support, tech transfer, and validation

Position Summary

The Director CAR-T Process Engineering and Technology Support leads a cross-functional team responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Oversees the process engineering, manufacturing support, MS&T Lab, technology transfer and packaging engineering. Provides technical 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

  • Maintain permanent inspection readiness and actively support regulatory inspections

  • Support optimization of the organizational structure to maximize productivity and communication flow

  • Support Sr. Director in developing 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

  • Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production

  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements

  • Interface with regulatory authorities as required to support Manufacturing Operations audits

  • Monitor plant performance metrics and support plant operating review meetings

  • Monitor the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management

  • Ensure employees have the resources needed to meet or exceed their goals; ensure adequate systems, procedures, personnel and equipment are in place.

  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.

  • Select and develop a well-trained, motivated and informed staff.

Leadership:

  • Create an environment of teamwork, open communication, and a sense of urgency

  • Lead as a change agent to promote flexibility, creativity, and accountability

  • Cascade 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

  • 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

  • 10 or more years of work experience in the biopharmaceutical or related industry

  • 8 or more years of people management experience

  • 8 or more years of manufacturing support or related experience in the biopharmaceutical 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.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.