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Director, CAR-T Operational Excellence and Systems

Req #: 1800999
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.

Summary

This position will lead all process and technology aspects to support the development, implementation, operation, and continuous improvement of the CAR T commercial supply chain.  The individual will work closely with all work streams within commercial supply chain and cross-functionally across the company to ensure enabling systems meet or exceed company objectives.  Specifically, this includes planning/scheduling, Chain Of Identity (COI), physical/information flows, and associated interfaces.  Also, includes interfaces with external systems. 

The role is charged with leading all aspects to support the global operational launch and on-going supply of highly innovative life-saving oncological cell therapies. These therapies represent a significant advancement in cancer treatment technology and patient responses. 

This role requires the incumbent to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization.

This is a highly integrated role touching many functions across the business and will require abilities to influence, negotiate, project plan, and project management, to drive alignment and performance across the business. 

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

  • Work with Senior Leadership Team to determine strategic direction and financial goals and align continuous improvement initiatives based on these needs
  • Identify business solution partners internal and external to build and deploy state of art CAR T cell therapy business process; create and update existing procedures
  • Business Process Architect for CAR T cell therapy Chain Of Custody (COC) and COI design
  • Work with sourcing and other stakeholders to create RFP for chain of custody, identity, condition monitoring software vendors establishing timelines, deliverables and ongoing KPIs
  • Provide guidance during the FDA filling process for chain of custody and identity solution design
  • Provide training support to business users as needed for CAR T supply chain process
  • Proactively work with key stakeholders in Global Pharmaceutical Development & Operations (GPD&O) and other external functions to develop a detailed understanding of complex business and technology needs.  Define and implement changes for improving business processes and related systems.
  • Manage application expansion & upgrade planning activities including business user requirements, project costs, schedules & resources, capital appropriation requests (CAR), cost-benefit analyses, user licenses, etc.
  • Act as functional project manager for changes to applications and business processes.  Coordinate project team members, consultants and subject matter experts in design, configuration, testing, deployment and post go-live support activities.  Track and monitor team progress and take steps to proactively remediate issues that adversely impact project budgets, schedules, resources and deliverables.
  • Act as a source of knowledge in areas of supply chain best practices and methodologies. Integrate supply chain best practices within business processes to enhance supply chain efficiency
  • Evaluate and identify solutions to business process & related system issues
  • Work cross-functionally to prepare process and technology related policies, standards, SOP’s and work practices including validation change controls, application testing, documentation management, incident and problem management, etc. Develop and manage global documentation as required
  • Manage the design and creation of management & operational reports
  • Be a source of business function knowledge for I.T. development groups
  • Remain current on new industry-based trends as well as supply chain best practices and applications by reading literature, attending conferences and seminars, taking classes and participating in industry events and networking as appropriate
  • Promote a mindset of continuous improvement, problem solving, and prevention
  • Ability to work strategically and independently with internal and external groups on multiple simultaneous projects

Skills/Knowledge Required:

  • At least 15 years of pharmaceutical GMP operations, manufacturing, or supply chain experience
  • At least 7 years of people management
  • Bachelor’s Degree, preferably in engineering, supply chain management, information systems, business management, life sciences, or related fields; Advanced degree a plus
  • Prior experience should include various supply chain operations including but not limited to supply chain planning, inventory management, manufacturing, warehousing, order management, logistics, etc.
  • People & project management experience, preferably in a matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills
  • Experience in fast-paced GMP startup, breakthrough designation product launch or similarly drug launch environment very desirable
  • Very strong influencing capabilities and must be able to interact and communicate effectively at all levels of the organization
  • 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
  • Must be competent in Project Management tools and methodologies
  • Excellent organizational and time management skills
  • Experienced in setting priorities and meeting deadlines in a fast-paced environment
  • Demonstrated strong aptitude in analysis, root causes identification, and problem solving
  • Able to synthesize information into a presentation appropriate to the organizational-level of the audience.  Able to summarize information concisely and communicate it using appropriate medium
  • Must be able to work with limited day-to-day supervision
  • Microsoft Office Suite experience required including; Excel; Outlook; PowerPoint; experience with forecast modeling tools and ERP systems
  • APICS certification is a plus


 

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.

#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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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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