Celgene Director, US Commercial CAR-T Apheresis Operations 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.
Global Pharmaceutical Development and Operations
The Director of US Commercial CAR T Apheresis Operations is accountable to manage business processes, supply chain, and operations for US commercial CAR T Apheresis Operations. This role may manage a team up to 30 people and is accountable for overall performance of US Apheresis Centers used for Celgene Commercial Chimeric Antigen Receptor (CAR) T-cell Therapies. This role is accountable for the right first time performance of all operations from patient scheduling up to delivery of the T-cells to the manufacturing facility. Scope of ownership for this role includes oversight of Apheresis Center screening due diligence, business onboarding, site contracting, CAR T process training, center qualification, ongoing center compliance, patient scheduling, lean six sigma process improvement projects, shipping and logistics for T-Cells, risk management, contingency planning, management of master service agreements for external services, and ongoing performance management of the country network of Apheresis Centers.
This role will be based in Summit NJ. Domestic travel up to 30% of time
Come join Celgene for this unique opportunity to be part of the team building a leading edge Commercial CAR T Platform that serves our patients with novel Celgene CAR T Therapies.
Responsibilities will include, but are not limited to the following:
Develop and manage US Commercial CAR T Apheresis Operations team
Foster relationships with Apheresis Center Staff, Hospital Staff, External Consultants/Contract Employees, and cross-functional Celgene CAR T team
Serve as regional lead for integrated business process management and reporting
Develop subject matter expertise in CAR T cell therapy
Develop and implement CAR T processes for Apheresis Operations
Develop and manage continuous improvement projects
Manage VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement
Manage successful onboarding, qualification, compliance, and performance of US Apheresis Center network
Manage selection, onboarding, and management of consultant/contract support
Manage change management of technical agreements, process changes, and equipment changes
Manage risk management strategy for shipping logistics, contingency plans, and system alarm parameters
Manage progress reports to summarize site and regional gaps, corrective actions and performance metrics
Collaborate with Clinical for ongoing clinical studies at Apheresis Centers in order to transition to commercial operating mode
Skill and Knowledge Requirements:
Required Undergraduate Degree in Life Sciences or Engineering
Required Minimum 10 years of experience in pharmaceutical industry (supply chain, technical operations, manufacturing, and/or quality)
Required Minimum of 5 years people management
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 medical terminology
Knowledge of applicable regulations and standards (AABB, FACT JACIE)
Knowledge of PDA and ICH Guidelines
High attention to detail skills
High organization skills with ability to multi-task several tasks in parallel
Preferred but not required:
Advanced degree in Life Sciences or Engineering
Experience in biopharmaceutical 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.