Celgene Director, CAR-T Manufacturing Business Operations and Supply Chain in Warren, 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.
The Director of CAR-T Manufacturing Business Operations reports to the Executive Director, Head of Warren Manufacturing. This role is accountable to manage Warren Manufacturing business continuity plan, annual department budget, business case creation/evaluation process, project management, operational excellence, and site supply chain. This role will manage business operations needed for a multi-product clinical manufacturing facility for Celgene Chimeric Antigen Receptor (CAR) T-cell Therapies. Responsible to matrix manage large cross-functional teams and will have several direct reports. Accountable for project and continuous improvement implementation for clinical manufacturing of new pipeline products and will lead development of a blueprint plan for best in class clinical manufacturing facility. Accountable for directing the site supply chain team for end-to-end planning, material procurement, and supply chain management of personalized cell therapies produced at the clinical manufacturing site. Responsible to develop supply strategies matching the needs of the clinical programs to ensure rapid delivery of products to patients. Provides oversight for production planning, material procurement, and material kitting activities in the manufacturing environment and is responsible for materials management, warehousing, inventory control, product tracking (chain of identity and chain of custody), import/export permits, shipping/receiving, and cold chain logistics.
Work scope will include clinical manufacturing for all cell therapy products, cell therapy technical platforms, and support of knowledge transfer from clinical to commercial manufacturing. This role will work with cross-functional leadership and subject matter experts including Manufacturing, Operational Excellence, Project Management, Global Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, IT, EHS, Finance, Regulatory, Clinical Specialists and Clinical Operations.
This position is based in Warren, NJ. Limited global travel up to 10% of time may be required.
Come join Celgene for this unique opportunity to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies.
Responsibilities will include, but are not limited to the following:
Management of direct reports and large cross-functional teams
Develop the manufacturing continuous improvement and high performing team culture
Foster a culture of compliance and strong environmental, health, and safety performance
Direct project, risk management, and contingency plans
Develop and implement change execution management strategies to ensure successful project execution
Develop and monitor department budget
Develop and manage continuous improvement projects
Lead VOC (voice of customer) and VOB (voice of business) surveys as needed
Lead implementation of CAPA projects related to deviation management
Ensure safe and compliant cGMP operations
Optimize internal capacity and capabilities to ensure clinical needs can be met.
Define supply strategy and supply agreements and/or contracts that include measures to ensure compliance
Develop overall raw material, component, and sourcing strategy and implement processes for ongoing assessment of supplier cost, quality, capacity, technical capabilities, best practices, security, and compliance
Ensure appropriate priorities, expectations, and results between the company and supply chain partners are defined using Service Level Agreements and Supply Contracts
Participate in the S&OP cycle and escalate of critical risks and issues for resolution
Establish a well-designed integrated demand and supply plan from raw materials to final distribution
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
Ensure staff are appropriately trained and qualified for the activities they perform
Support production related investigations, ensuring compliance with internal standards and regulatory requirements
Create an environment of teamwork, open communication, and sense of urgency
Lead as a change agent to promote flexibility, creativity, and accountability
Deliver business results through timely and quality decision making
Develop executive presentations and reports for the Manufacturing Leadership Team
Skill and Knowledge Requirements:
<>§<>§<>§<>§Ability to rapidly solve problems and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Knowledge of PDA and ICH Guidelines
High attention to detail skills
High organization skills with ability to multi-task several objectives in parallel
Required Bachelor’s Degree and Master’s Degree in Life Sciences or Engineering
Required Minimum 15 years of experience in pharmaceutical industry (development, supply chain, technical operations, manufacturing, and/or project management)
Required Minimum 5 years of people management experience
Preferred but not required:
Master’s degree in Life Sciences or Engineering or Supply Chain
Certification in CPIM, CSCP, and/or CLTD
Certification in PMP and/or LSS
Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization
Experience with lean six sigma projects and change execution management
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.