Director, EU Commercial CAR T Apheresis Operations

Req #: 1801970
Location:Boudry, NeuchatelCH
Job Category:Quality
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene Corporation
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry; Germany- Munich

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.

Director, EU Commercial CAR T Apheresis Operations

Boudry, Switzerland

SUPERVISOR

Sr. Director, Global Head Apheresis Operations

PRE-REQUISITES

Undergraduate Degree in Life Sciences or Engineering, minimum 10 years of experience in pharmaceutical industry, minimum 5 years of people management

Role Description:

The Director of EU Commercial CAR T Apheresis Operations is accountable to manage business processes, supply chain, and operations for EU Commercial CAR T Apheresis Operations.  This role may manage a team up to 30 people and is accountable for overall performance of EU 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 regional network of Apheresis Centers. 

This role is based out the Boudry, Switzerland Celgene Site.  Regional travel up to 30 to 50% 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 manage EU 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 EU 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:

• 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 (JACIE)


• Knowledge of PDA and ICH Guidelines


• 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


• Required Minimum 10 years of experience in pharmaceutical industry (supply chain, technical operations, manufacturing, and/or quality)


• Required Minimum of 5 years people management


• Required written and verbal fluency in English, German, and French languages

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


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