Associate Director/Director, CAR-T Apheresis OperationsTechnical Expert
Other Locations:US- NJ- Summit West
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
#LI-POSTCelgene 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.