Celgene Lead, CAR-T Warehouse Operations in Summit, New Jersey
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.
Lead, CAR-T Warehouse OperationsSummit, NJ
Supervisor, CAR-T Warehouse Operations
Purpose and Scope of Position
Manages material needs/requirements for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Warehousing Operations Management. The position must adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication and initiation of production deviations and assistance with quality investigations are required, as applicable.
Required Competencies: Knowledge, Skills, and Abilities
Ability to work as team
Advanced knowledge of cGMP/FDA regulated industry
Intermediate written and verbal communication skills
Intermediate knowledge of OSHA, DEA, and USP
Intermediate mathematical skills
Intermediate Proficiency in MS Office applications
Inventory control and management including proficiency in lot / batch segregation, expiration dating, and temperature storage requirements
Technical writing capability
Advanced warehouse management system experience
Supervisory skills to provide direction and support of warehouse material handler positions
Background to include an understanding of biology, chemistry, medical or clinical practices is a plus
Duties and Responsibilities
Works in a team based, cross-functional environment to complete warehousing tasks required by shift schedule
Records material handling / warehouse operations data and information in a clear, concise, format according to proper cGxP requirements
Performs inspection and receipt of incoming raw materials and components in coordination with defined specifications and in collaboration with Incoming Quality Control
Performs inventory control: cycle counts, material stocking, scrapping
Performs kitting operations
Completes inventory / material transfer and movement within facility
Manages material expiry, lot / batch control, allocation and maintains material condition requirements
Quantifies and maintains materials in inventory locations
Maintains timing according to the production schedule to ensure on-time material transfers and availability
Completes transactions within an electronic warehouse management system
Performs inspection and receipt of incoming Apheresis and PBMC and prepares final product shipments for couriers
Proactively manages inventory levels within locations to ensure appropriate safety stock / minimum levels are maintained
Conducts periodic safety inspections of warehouse areas and equipment
Completes training requirements in accordance to defined schedule / curricula
Provides on-the-job and classroom training to all departments within the CAR T organization
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 warehouse operations including but not limited to Manufacturing, Quality, Materials Management, Process & Technology.
Performs system testing along with all appropriate documentation of test scripts
Provides back up supervisory support
Other duties may be assigned, as necessary
Education and Experience (As Applicable)
High School diploma/GED or equivalent required and 10+ years of relevant Warehouse or Manufacturing Operations within an cGxP or regulated environment
OR Associate/Technical degree and 5+ years of relevant Warehouse or Manufacturing Operations within an cGxP / regulated environment
OR Bachelor’s degree and 2+ years of relevant Warehouse or Manufacturing Operations within an cGxP / regulated environment
An equivalent combination of education, experience and training may substitute
Working Conditions (US Only)
Routine exposure to human blood components and Must be able to work in an environment with blood derived components.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Available to work OT when business requires.
Flexible to work across both Summit and Warren NJ sites.
Willing to work staggered day shift hours.
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
Flexibility to don clean room garments and personal protective equipment (PPE).
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
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, handheld devices and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift from 25- 50 pounds.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
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.
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, support and access to our innovative therapies.