Celgene Director, CAR-T Process Engineering & Tech Support in Summit, New Jersey
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.
Experience in biologic/vaccine manufacturing support, tech transfer, and validation
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.
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
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
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.