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Sr Supervisor, QC Training CAR-T

Req #: 1800854
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.

QC Senior Supervisor Training, QC Systems and Services CAR-T

Summit, NJ

1.      Purpose and Scope of Position

The QC Senior Supervisor Training is responsible for managing the training program for analytical and microbiology CAR-T QC laboratories.  This includes, but is not limited to, establishing and maintaining curriculum for lab personnel, assisting with on the job training, and working with SMEs to schedule training.  Additionally, the QC Senior Supervisor Training will manage the training laboratories and assist with related projects in support of maintaining training proficiency.  This position will work closely with the site’s training and development team.

2.      Required Competencies: Knowledge, Skills, and Abilities

  • Advanced knowledge of cGMP training requirements
  • Advanced knowledge of cGMP training software and aids
  • Advanced knowledge of cGMP Learning Management Systems and other enterprise applications
  • Knowledge of cGMP Regulations and how they apply to QC laboratory activities
  • Experience in performing training in a cGMP regulated environment
  • Advanced written and verbal communication and presentation skills
  • Proficiency in Microsoft Office applications
  • Strong collaboration and organization skills
  • Ability to effectively network and benchmark within and outside the organization
  • Ability to challenge processes to improve quality, efficiency, and compliance
  • Ability to work independently for extended periods of time
  • Ability to interact with internal and external auditors as a Subject Matter Expert (SME)
  • Ability to work collaboratively on cross-functional teams
  • Ability to set priorities for the QC training group and manage timelines
  • Ability to mentor and develop personnel

3.      Duties and Responsibilities

      Develop and maintain training curriculum

  • Work with lab SMEs and training department to establish appropriate curriculum for lab personnel
  • Work with lab SMEs and training department to complete new hire training
  • Work with training department and SMEs to ensure that QC lab personnel are appropriately trained to perform relevant tasks
  • Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding
  • Utilize training resources across multiple groups
  • Implement best training practices as appropriate

Manage Training Laboratories

  • Establish Training laboratory facility to accommodate on the job training across multiple QC methods
  • Maintain training laboratories including training schedules
  • Manage and facilitate on the job and instructor lead training
  • Manage and facilitate on the job and instructor lead trainings

·      Independently develop and write training materials/documents

Serve as Training SME

  • Support enterprise training and other departmental training as appropriate
  • Develop and deliver training presentations on pertinent topics to large groups of personnel on an as needed basis, including annual refresher training, remedial training and on as a needed basis to support QC
  • Process and file training records
  • Maintain training metrics

      Team leadership

  • Provide guidance and coaching, mentoring, and support that focuses on performance improvement
  • Serve as author or technical reviewer of appropriate departmental procedures
  • Perform approvals for relevant training activities

       Performs other tasks as assigned.

4.      Education and Experience

  • Bachelor’s Degree required, preferable in Science
  • Advanced Degree preferred
  • 6+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for developing or delivering training to colleagues and/or managing a training program
  • Experience with current Good Manufacturing Practices (cGMPs) and 21 CFR 210/211
  • Experience and understanding of biological manufacturing processes and aseptic techniques a plus
  • An equivalent combination of education and experience may substitute

5.      Working Conditions

  • The incumbent will be working in 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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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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