Celgene Lead, CAR-T Warehouse Operations in Summit, New Jersey

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.

Lead, CAR-T Warehouse OperationsSummit, NJ

Manager

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.

#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.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.