CAR T Supply Chain Supervisor - Warren , New Jersey, United States, 07059
Location: Warren, New Jersey, United States
Job Category: Technical Development
Work Location: 7 Powder Horn Drive 07059
Organization: Supply Chain
Employee Status: Full-time
Job Type: Regular
Purpose and Scope of Position
This role is accountable to supervise supply chain functional duties for a multi-product clinical manufacturing facility for Celgene Chimeric Antigen Receptor (CAR) T-cell Therapies and will have direct reports. Responsible for planning, material handling, and supply chain management of personalized cell therapies produced at the clinical manufacturing site. Responsible for materials management, inventory control, product tracking (chain of identity and chain of custody), import/export permits, shipping/receiving, and cold chain logistics.
Manages team of coordinators for cold chain and patient material receipt, release, dispensing, inventory, and shipping for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments. The position must adhere to regulatory requirements while performing job functions. Job duties are performed in alignment with CAR-T production schedules, may require weekend work. Communication and initiation of production deviations and assistance with quality investigations are required, as applicable. This opportunity is for a standard weekday shift: M-F, 9:00am - 5:30pm. Overtime may be required at management discretion including on weekends.
Work scope will include clinical manufacturing for all cell therapy products. This role will work with Manufacturing, Project Management, Operational Excellence, MS&T, Quality Assurance, Global Supply Chain, Process Development, Patient Operations, Clinical Specialists and Clinical Operations.
This position is based in Warren, NJ. Limited global travel up to 10% of time may be required.
Come join Celgene for this unique opportunity to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies.
Required Competencies: Knowledge, Skills, and Abilities
- Ability to lead a team/manage direct reports
- Advanced written and verbal communication and mathematical skills
- Inventory control and management including lot / batch segregation, expiration dating, and temperature storage requirements
- Background to include an understanding of biology, chemistry, medical or clinical practices preferred, not required
- Oracle experience preferred, not required
- Manages supply chain coordinators completing the following tasks:
- Records patient material handling / operations data and information in a clear, concise, format according to proper cGxP requirements
- Performs inspection and receipt of incoming patient materials per cold chain shipping requirements in coordination with defined specifications and in collaboration with Incoming Quality Control
- Performs inventory control: cycle counts, material stocking, scrapping, destruction
- Completes inventory / material transfer and movement within facility
- Manages material expiry, lot / batch control, allocation and maintains material condition requirements
- Completes transactions within an electronic data management system, i.e. Oracle
- Performs inspection and receipt of incoming Apheresis and PBMC and prepares final product shipments for couriers
- Maintains timing according to the production schedule to ensure on-time material transfers and availability
- Conducts periodic safety inspections of areas and equipment
- Completes training requirements in accordance to defined schedule / curricula
- Periodically reviews and provides input on revisions to SOPs related to functional responsibilities
- Provides support for investigations and issue resolution
- Assists with resolution of inbound issues (receiving, suspect damages, shipment errors)
- Identifies process and performance improvement opportunities
- Collaborates with outside departments for CAR-T operations including but not limited to Manufacturing, Quality, Materials Management, Process & Technology.
- Performs system testing along with all appropriate documentation of test scripts
- Available to work OT when business requires
- Gathers data and maintains Supply Chain metrics for clinical supply
- Serve as single point of contact between Global Patient Operations, Global Supply Chain and site
- Manage cell material handling and storage for leukapheresis, intermediate and drug product
- Ensure staff are appropriately trained and qualified for the activities they perform
- Support production related investigations, ensuring compliance with internal standards and regulatory requirements
- Create an environment of teamwork, open communication, and sense of urgency
- Lead as a change agent to promote flexibility, creativity, and accountability
- Build trust and effective relationships with peers and stakeholders
- Foster a culture of compliance and strong environmental, health, and safety performance
- Promote a mindset of continuous improvement, problem solving, and prevention
- Other duties may be assigned, as necessary
- Must have a valid driver's license
- Required Bachelor s Degree in Science, Supply Chain, or equivalent
- Required Minimum 5 years of experience in pharmaceutical industry
- Required Minimum 2 years of people management experience
- Certification in CPIM, CSCP, and/or CLTD
- Must be able to work in a cleanroom environment and perform aseptic processing
- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
- Ability to crouch, bend, twist, and reach
- Physical dexterity sufficient to use computers and documentation
- Must be able to work in Lab setting with biohazards/ various chemicals/ strong magnets
- Ability to stand /sit/walk for long periods of time and work different hours of the day
- Ability to lift/ push/ pull 50 lbs independently
- Must be able to perform activities with repetitive motions
- Must be able to wear clean room garments and personal protective equipment (PPE).
- Must be comfortable being exposed to human blood components.
- Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements. Must be comfortable in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
- Based on work assignment, may be recommended (or required) to have medical and visual screening testing in accordance with the company s Occupational Health Program
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.
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.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
\"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.\"
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information..... click apply for full job details