Celgene Sr Manager, EU Commercial CAR T Apheresis Operations in Offsite, Germany

Description

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.

Sr. Manager/Manager Commercial CAR T Apheresis Operations

LOCATION

EU – Multiple positions regionally field based in London, Berlin, Hamburg, Munich, Cologne, Frankfurt, Paris, Milan, Rome, Madrid

SUPERVISOR

Director, EU Commercial CAR T Apheresis Operations

PRE-REQUISITES

Undergraduate Degree in Life Sciences or Engineering, minimum 4 years of experience in a regulated environment either hospital or pharmaceutical

Role Description:

The Commercial CAR T Apheresis Operations Sr. Manager/Manager is accountable to manage onboarding 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 designated region of Europe 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 onboarding, 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 is regionally based out of home office to service designated regions of Europe (Germany, UK, France, Italy, Spain). Regional travel up to 75% of time within Europe 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 applicable regulations and standards (JACIE)

  • 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

  • Required Undergraduate Degree in Life Sciences or Engineering (Registered Nurse, Biomedical Engineer)

  • Required Minimum 4 years of experience in a regulated environment either hospital or pharmaceutical

  • Required written and verbal fluency in English language and assigned region language (German, French, Spanish, or Italian)

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 Nurse 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, voice of customer, voice of patient analysis

  • Written and verbal fluency in several languages (English, German, French, Spanish, Italian)

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.

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