Sr. Manager, CAR-T Apheresis Operations

Employer
Celgene
Location
San Diego, CA
Posted
Apr 30, 2018
Ref
1801412
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- WA- Bothell JuMP; US- WA- Seattle; US- CA- San Diego; US- CA- Los Angeles; US- AZ- Phoenix; US- KS- Kansas City; US- IL- Melrose Park; US- CA- San Francisco- Emeryville; US- CA- Offsite


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 USRole Description:

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

  • Negotiation 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

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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.