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Sr Director, CAR-T Planning & Operations

Req #: 1700574
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 Sr Director of CAR-T Planning and Operations is responsible for building and managing the operations for the global launch of multiple life-saving innovative personalized cell therapies to fight critical unmet medical needs. These therapies will include several collaboration therapies.

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

  • Lead team that will design, build, and manage innovative and industry-leading vein-to-vein cell journey and Chain of Identity/Chain of Custody for autologous cell therapy
  • Build and lead team to manage hub that will act as operational center coordinating with Commercial teams, Apheresis/Infusion sites, couriers/logistics companies, and Manufacturing
  • Inventory management and development of inventory policy
  • Raw materials purchasing
  • Manufacturing scheduling of patient production lots
  • Label Operations
  • S&OP management
  • Demand and capacity planning
  • Lead team of direct material buyers/planners
  • Control costs to ensure lowest COGS while balancing assurance of supply, supplier quality, and supplier service          
  • Work with Quality, IT, Manufacturing, Commercial, Regulatory in cell journey design/build
  • Work with Sourcing to ensure appropriate contractual structure to ensure raw material supply plan will meet forecast and inventory requirements
  • Ensure compliance with current federal, state, and local regulations
  • Meet or exceed timeline objects for operational readiness milestones
  • Assist in managing the budget and ensure department adheres to the approved budget
  • Build and manage team to achieve above
  • Other duties as assigned

Leadership, Values and Behaviors:

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

Education:

  • Bachelor’s Degree, preferably in business, science or operations
  • APICS certification preferred
  • Lean/Six Sigma certification preferred
  • Masters or graduate degree preferred

Competencies/Experience Required:

  • At least 10-15 years of pharmaceutical GMP operations, manufacturing, supply chain, or planning
  • At least 5-7 years of management experience, with experience building teams, and with coaching and managing people managers
  • Proven track record of leadership and accomplishment in fast-paced GMP startup, breakthrough designation product launch or similarly drug launch environment very desirable
  • Autologous cell therapy experience very desirable
  • Very Strong communication and influencing capabilities
  • Knowledge of best practices within manufacturing scheduling, planning, inventory management and supply chain
  • Strong working knowledge and understanding of GMP, and other relevant ICH and FDA guidelines
  • Excellent verbal and written communication skills and confidently communicate with all staff levels
  • Process-oriented with strong analytical skills for risk identification and management
  • Availability to travel
  • Flexibility to work cross-functionally
  • Strong intercultural capabilities
  • Deep analytical skills
  • Solid financial acumen

#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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