Director, Global CAR-T Apheresis Operations Project Management

Employer
Celgene
Location
Summit, NJ
Posted
Apr 30, 2018
Ref
1801381
Required Education
Bachelors Degree
Position Type
Full time

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.

DEPARTMENT

Global Pharmaceutical Development and Operations

Role Description:

The Director of Global CAR T Apheresis Operations Project Management is accountable to manage global projects needed to build and improve the Global Apheresis Operations capability for Celgene Chimeric Antigen Receptor (CAR) T-cell Therapies.  This role will matrix manage large cross-functional teams and may have direct reports.  This role is accountable for operational excellence improvement projects to ensure right first time performance of all operations from patient scheduling up to delivery of the T-cells to the manufacturing facility.  Project scope will include 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, setting up master service agreements for external services, and ongoing performance management.  Global scope will include execution of projects in North America, Europe, and Japan.

This role will be based in Summit NJ.  Global travel up to 30% 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:

  • Management of large cross-functional teams

  • Implement change execution management strategies to ensure successful project execution

  • Serve as global lead for Apheresis Operations project management and continuous improvement

  • 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 process for VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement

  • Create and manage the dashboard to monitor the onboarding, qualification, compliance, and performance of Global Apheresis Center network

  • Create and manage the risk management dashboard for Global Apheresis Operations

  • Manage selection, onboarding, and management of consultant/contract support

  • Develop risk management strategy for shipping logistics, contingency plans, and system alarm parameters

  • Collaborate with Clinical for ongoing clinical studies at Apheresis Centers in order to transition to commercial operating mode

Skill and Knowledge Requirements:

  • Ability to work independently

  • Ability to matrix manage a large cross functional team

  • Ability to manage portfolio of projects that are concurrently ongoing

  • 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 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

  • People and project management skills

  • Negotiation skills

  • Customer focused relationship skills

  • Proficient computer skills with Microsoft Word, Excel, PowerPoint, Project; Visio

Qualifications and Experience 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 of project management

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

  • PMP

#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.