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Associate Director, CAR-T Warehouse Operations

Req #: 1801143
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.

Department:

Supply Chain Operations

Purpose of the Position:

The Associate Director, CAR T Warehouse Operations leads a team managing all processes associated with material receipts, movement, storage and distribution within CAR T clinical and commercial operations.  This position plays a strategic role in the CAR T warehousing processes ensuring appropriate controls and efficient operations. The Associate Director leads multiple warehouse supervisors and material handlers across multiple warehouse locations and multiple shifts. As a member of the CAR T Supply Chain Operations leadership team, collaborate with internal and external stakeholders to meet objectives and goals.

Essential Functions:

  • Build, maintain and lead a high achieving organization to support late phase clinical trial and commercial CAR T warehousing activities
  • Manage daily operational activities associated with kitting, receiving of Apheresis and PBMC shipments, all movement of materials through the CAR T supply chain network and preparation of drug product shipments
  • Engage in various groups to manage and expedite receipt along with ensuring appropriate sampling / inspection of incoming materials
  • Work with CAR T Materials Management Organization to build short and long-term capacity models for all warehouse space requirements including controlled room temperature, refrigerated and freezer storage
  • Develop staffing models and personnel requirements to ensure department is appropriately staffed to meet all short and long-term capacity requirements
  • Ensure development, implementation and maintenance of appropriate training curricula
  • Manage the creation, implementation and compliance for all documentation, procedures and policies
  • Lead and manage the development of corrective and preventative actions, deviation responses and investigations for warehouse operations
  • Efficiently coordinates, communicates, and provides essential Warehouse Operations project information and activities status to Development, Clinical, Planning, Manufacturing, Quality Assurance, Global Supply and other associated functions in a timely manner without becoming the critical path
  • Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources
  • Lead multi-functional and multi-location teams through project identification and implementation
  • Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability
  • Build a collaborative environment that fosters decisive decision making and accountability
  • Build trust and productive relationships with peers and stakeholders
  • Deliver business results through timely and quality decision making
  • Fosters a culture of high ethics and compliance
  • Promote a mindset of continuous improvement, problem-solving and prevention
  • Create an environment of teamwork, open communication, and a sense of urgency
  • Drive collaboration across the company and external partners
  • Develop, maintain and actively manage relationships with customers and external partners to ensure optimize total cost of ownership
  • Provide a safe and healthy work environment for staff within areas and ensure compliance with all appropriate policies and regulations
  • Develop business continuity plans to ensure sustainable operations
  • Develop dashboard to monitor performance against metrics and KPIs

Required Competencies-Knowledge, Skills, and Abilities:

  • Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
  • Advanced knowledge warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation and qualification
  • Proficiency in ERP systems / WMS Applications and analytics tools
  • Advanced proficiency in MS Office applications
  • Advanced analytical, problem-solving, and critical thinking skills
  • Advance project management experience handling multiple projects simultaneously
  • Advanced written and verbal communication skills
  • Advanced presentation development and delivery skills
  • Advanced organizational and time management skills
  • Ability to travel 10% - 20% of time

Education & Experience:

Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields; advanced degree preferred.

15+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.

7+ years experience in warehousing, manufacturing and supply chain areas.

Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique

An equivalent combination of education, experience and training may substitute.

Working Conditions:

  • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. 
  • Physical dexterity sufficient to use computers and documentation.
  • Sufficient vision and hearing capability to work in job environment.
  • Ability to lift up to 25 pounds.
  • Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
  • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
  • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
  • Flexibility to don clean room garments and personal protective equipment (PPE).
  • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
  • Routine exposure to human blood components.
  • Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

#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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