Celgene Associate Director/Director, CAR-T Apheresis OperationsTechnical Expert 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/Associate Director CAR T Apheresis Operations Technical Expert is accountable to manage clinical process performance of Commercial Apheresis Operations for the Celgene Commercial Chimeric Antigen Receptor (CAR) T-cell Therapies. This role will manage a global portfolio of CAR T products. This role may manage cross-functional teams of people to implement process changes that drive clinical improvements in patient care therapies. This role is accountable for the process ownership and successful transition from clinical studies to routine commercial operations. This role will serve as a global subject matter expert for apheresis and patient care. This role will lead patient focused continuous improvement initiatives and will support the right first time performance of all operations from patient scheduling up to delivery of the T-cells to the manufacturing facility.
This role will be based in Summit NJ. Global travel up to 40% of time may be required.
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:
Foster relationships with Global Apheresis Center Staff, Hospital Staff, External Consultants/Contract Employees, and cross-functional Celgene CAR T team
Serve as global lead for clinical processes for apheresis and patient care
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
Support successful onboarding, qualification, compliance, and performance of Global Apheresis Center network
Support selection, onboarding, and management of consultant/contract support
Lead change management of process and patient care changes
Support risk management strategy, contingency plans, and deviation management
Manage process data and issue process reports to summarize patient and product performance
Collaborate with Clinical for ongoing clinical studies at Apheresis Centers to facilitate transition to commercial operating mode
Skill and Knowledge Requirements:
Required Advanced Degree in Life Sciences or Engineering
Required Minimum 10 years of experience in pharmaceutical industry or clinical hospital practice
Required Minimum of 5 years of experience in apheresis center operations
Ability to rapidly solve problems and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Strong Medical, scientific and clinical knowledge
Knowledge of applicable regulations and standards (AABB, FACT JACIE)
Knowledge of PDA and ICH Guidelines
Knowledge of CAR T process and therapies
Knowledge in the treatment of hematologic malignancies including acute leukemia, non-Hodgkin lymphoma, and multiple myeloma
High attention to detail skills
High organization skills with ability to multi-task several tasks in parallel
Preferred but not required:
MD or Ph.D.
Experience in biopharmaceutical clinical to commercialization for CAR T
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.