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Manager, QC Investigations CAR-T

Req #: 1800784
Location: Summit, NJ US
Job Category: Quality
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Employee Status: Full time
Job Type: Regular
Job Level:
Other Locations:US- NJ- Summit West


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.

Manager, QC Investigation CAR-T

Summit, New Jersey

1.      Purpose and Scope of Position

The QC Investigation’s Manager is responsible for supporting compliance related activities within the Quality Control department  in direct support of clinical and commercial CAR-T  manufacturing activities. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, author protocols/reports, and troubleshoot.  Additionally, the QC Investigation’s Manager will be responsible for continuous compliance improvements within the QC department.

2.      Required Competencies: Knowledge, Skills, and Abilities

  • Advanced knowledge/hands on experience with analytical and microbiology laboratory equipment, techniques, and procedures.
  • Advanced ability to accurately and completely understand, follow, interpret, apply Global

Regulatory and cGMP requirements.

  • Advanced ability to interact with regulatory auditors as Subject Matter Expert (SME).
  • Advanced technical writing skills.
  • Advanced problem-solving ability/mentality, technically adept and logical.
  • Ability to represent the interests of the group on cross-functional teams.
  • Ability to set priorities of the group and manage timelines.
  • Ability to work with management locally and globally.
  • Advanced knowledge of data trending and tracking, including use of statistical analysis software.
  • Advanced ability to communicate effectively with peers, department management and cross- functional peers.
  • Advanced knowledge of change control processes.
  • Advanced knowledge of quality systems used to document investigations.
  • Advanced knowledge and ability to appropriately utilize root cause analysis tools.
  • Ability to mentor and develop personnel.

3.      Duties and Responsibilities

  • Manage and/or perform EM and OOS laboratory investigations.
  • Perform thorough root cause analysis (RCA).
  • Create and maintain the laboratory OOS procedures.
  • Create and manage the training program for performing laboratory investigations.
  • Ensure all deviations/investigations are completed in an expedited manner.
  • Provide technical support for manufacturing deviations/investigation.
  • Manage triage meetings for deviations/investigations.
  • Represent QC during audits/inspections for deviation/investigation related inquiries.
  • Initiate and execute change controls and CAPAs.
  • Capable of handling complex issues and solving problems with minimum guidance.
  • Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.

Carry out management authority for review and approval activities

  • Serve as author or technical reviewer of appropriate departmental procedures.
  • Review documentation as required by laboratory procedures.
  • Perform approvals for relevant laboratory activities.

4.      Education and Experience

  • Requires a Bachelor’s Degree in Biochemistry, Immunology, Molecular and Cellular Biology, or Biology
  • Advanced Degree preferred.
  • 7-10 years of relevant work experience, preferably in a regulated environment.
  • Previous experience in a gene or cell therapy facility is preferred.
  • An equivalent combination of education and experience may substitute.

5.      Working Conditions

  • The incumbent must analyze numerical values on a daily basis.
  • The incumbent will be working a laboratory setting up to six (6) hours per day.
  • The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this positionThe 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 positionThere are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this jobEmployees 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.
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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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