Celgene Sr. Manager, CAR-T Apheresis Operations in San Francisco, California
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.
USA - Summit, NJ or Regionally Based within Eastern, Central, or Western US
The Commercial CAR-T Apheresis Operations Sr. Manager/Manager is accountable to manage on boarding and performance of Apheresis Centers used for Celgene Commercial Chimeric Antigen Receptor (CAR) T-cell Therapies. This role will serve as the technical operations single point of contact for up to 20 Apheresis Centers located within the United States and may require management of contract employees. 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 Apheresis Center screening due diligence, business on boarding, 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, and ongoing performance management of assigned centers.
This role can be based out of Corporate Headquarters in Summit NJ or regionally based out of home office to service Eastern, Central, or Western United States. Domestic travel up to 75% of time within the United States 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:
Develop and foster relationships with Apheresis Center Staff, Hospital Staff, External Consultants/Contract Employees, and cross-functional Celgene CAR T team
Develop subject matter expertise in CAR T cell therapy
Develop and implement CAR T process training materials
Develop and manage continuous improvement projects
Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement
Facilitate successful onboarding, qualification, compliance, and performance of assigned Apheresis Centers
Facilitate selection, onboarding, and management of consultant/contract support
Own change management of technical agreements, process changes, and equipment changes
Serve as primary contact for triage of deviations or field questions and drive resolution
Develop risk management strategy for shipping logistics, contingency plans, and system alarm parameters
Collect and enter data into electronic data management systems
Author 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:
Ability to rapidly solve problems and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Medical, scientific and clinical knowledge
Knowledge of medical terminology
Knowledge of applicable regulations and standards (AABB, FACT JACIE)
Knowledge of PDA and ICH Guidelines
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
People and project management skills
Customer focused relationship skills
Proficient computer skills with Microsoft Word, Excel, PowerPoint, Project
Qualifications and Experience Requirements:
Required Undergraduate Degree in Life Sciences or Engineering (RN, Biomedical Engineer)
Required Minimum 4 years of experience in a regulated environment either hospital or pharmaceutical
Preferred but not required:
Advanced degree in the Life Sciences or Engineering (e.g. Pharm D, NP, PA, Biomedical Engineer)
Experience managing an apheresis center a plus (i.e. Apheresis Director, Apheresis Manager)
Prior customer facing role in pharmaceutical industry
Experience collecting cells via apheresis
Working experience in the treatment of hematologic malignancies including acute leukemia, non-Hodgkin lymphoma, and multiple myeloma
Experience with lean six sigma projects
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.