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Director, US Commercial CAR-T Apheresis Operations

Req #: 1801101
Location: Summit, NJ US
Job Category: Quality
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit West

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.

DEPARTMENT

Global Pharmaceutical Development and Operations

Role Description:

The Director of US Commercial CAR T Apheresis Operations is accountable to manage business processes, supply chain, and operations for US commercial CAR T Apheresis Operations.  This role may manage a team up to 30 people and is accountable for overall performance of US Apheresis Centers used for Celgene Commercial Chimeric Antigen Receptor (CAR) T-cell Therapies.  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 oversight of Apheresis Center screening due diligence, business onboarding, site contracting, 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, management of master service agreements for external services, and ongoing performance management of the country network of Apheresis Centers. 

This role will be based in Summit NJ.  Domestic travel up to 30% of time

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 manage US Commercial CAR T Apheresis Operations team
  • Foster relationships with Apheresis Center Staff, Hospital Staff, External Consultants/Contract Employees, and cross-functional Celgene CAR T team
  • Serve as regional lead for integrated business process management and reporting
  • 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
  • Manage successful onboarding, qualification, compliance, and performance of US Apheresis Center network
  • Manage selection, onboarding, and management of consultant/contract support
  • Manage change management of technical agreements, process changes, and equipment changes
  • Manage risk management strategy for shipping logistics, contingency plans, and system alarm parameters
  • Manage 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:

  • Required Undergraduate Degree in Life Sciences or Engineering
  • Required Minimum 10 years of experience in pharmaceutical industry (supply chain, technical operations, manufacturing, and/or quality)
  • Required Minimum of 5 years people management
  • Ability to rapidly solve problems and deal with organizational complexity
  • Ability to prioritize and complete work with sense of urgency based on criticality
  • Knowledge of medical terminology
  • Knowledge of applicable regulations and standards (AABB, FACT JACIE)
  • Knowledge of PDA and ICH Guidelines
  • High attention to detail skills
  • High organization skills with ability to multi-task several tasks in parallel

Preferred but not required:

  • Advanced degree in Life Sciences or Engineering
  • Experience in biopharmaceutical supply chain, manufacturing, and commercialization
  • Experience with lean six sigma projects and change execution management

#LI-POST

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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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