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Director, CAR-T Supply Chain

Req #: 1700499
Location: Summit, NJ US
Job Category: Manufacturing/Technical Operations
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.

The Director CAR-T Supply Chain is responsible for supporting multi-site manufacturing, including materials management, kitting, GMP/non-GMP warehousing, shipping, receiving, and inventory management for innovative personalized cell therapies produced at the Summit NJ commercial and clinical plant and Warren NJ development and training plant

Responsibilities include, but are not limited to, the following:

  • Ensure safe and compliant cGMP operations 
  • Maintain permanent inspection readiness and actively support regulatory inspections
  • Design org structure, hire, train, develop, direct, mentor, and evaluate team members to accomplish goals. 
  • Ensure compliance with current federal, state, and local regulations
  • Design and build processes to support Manufacturing, Supply Chain, and GPDO needs and objectives
  • Support implementation of appropriate systems that may include WMS, Chain of Identity, MES, and others
  • Meet or exceed timeline objects for operational readiness milestones
  • Manage pick and pack system for supply kits to manufacturing groups utilizing a Bill of Materials
  • Manage receiving and shipment of final product
  • Monitor commercial/clinical inventory report for quantity, lot status, expiration dates
  • Interface and coordinate with Manufacturing, Apheresis Operations, and Supply Chain
  • Oversee or participate in investigations, deviations, CAPAs
  • Implement metrics to track and manage completion of objectives and projects
  • Allocate resources to ensure plans are met within the schedule and budget
  • Ensure staff are appropriately trained and qualified for the activities they perform
  • Support investigations as needed
  • Monitor plant performance metrics and support plant operational review meetings
  • Assist in managing the budget and ensure department adhere to the approved budget
  • Other duties as assigned

Leadership, Values and Behaviours:

  • Lead as a change agent in fast-paced environment to promote flexibility, creativity, and accountability
  • Create an environment of teamwork, open communication, and sense of urgency
  • Establish clear strategic goals and objectives for the organization that are linked to the overall company strategy
  • Drive strong collaboration within the plant, across the company, and across the network
  • Build trust and effective relationships with peers and stakeholders
  • Deliver business results through timely and quality decision making
  • Foster a culture of compliance and strong environmental, health, and safety performance
  • Promote a mindset of continuous improvement, problem solving, and prevention

Education:

  • Bachelor’s Degree, preferably in business or operations.

Competencies/Experience Required:

  • Autologous cell therapy operations experience strongly preferred
  • Proven track record of leadership and accomplishment in breakthrough designation or other fast-paced environments
  • At least 15 years of relevant GMP supply chain, warehouse/distribution, and materials management at a pharmaceutical, medical device, or biotech company
  • Strong leadership and team building and management
  • Strong working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines
  • In depth knowledge of GMP and non-GMP warehousing, inventory management, and kitting operations in a pharmaceutical manufacturing setting
  • ERP systems, with Oracle strongly preferred
  • Leadership skills that motivate and energize a group or an individual for top performance.
  • Excellent verbal and written communication skills and confidently communicate with all staff levels
  • Demonstrated technical skills in Materials Management
  • Experience preparing and leading Regulatory Agency Inspections
  • Process-oriented with strong analytical skills for risk identification and management
  • Proficient in MS word, Excel, PowerPoint, Outlook and warehouse management software
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Comfortable operating with minimal direction and able to adjust workload based upon changing priorities
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Ability to think strategically and to translate strategy into actions
  • 5-7 or more years of people management experience

#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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