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Manager, CAR-T Assay Transfer

Req #: 1700633
Location: Warren, NJ US
Job Category: Quality
Work Location: 7 Powder Horn Drive WARREN 07059
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Warren

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.

Responsibilities will include, but are not limited to, the following:

The Manager of Assay Transfer will be responsible for transferring qualified or validated analytical methods from the Analytical Research and Development group into QC Operations.  This role will be responsible for collaborating on the validation efforts for all new analytical methods and primarily developing the analytical transfer plans into routine QC Operations.

It is expected that the role will facilitate training for all QC operators.  The successful candidate will demonstrate proficiency in technical writing, developing SOPs, training, and show high-level technical ability in flow cytometry, PCR, and ELISA.  Critical to this role is an understanding and familiarity with principles of assay and equipment validation.

This individual will work with minimal supervision to craft yearly performance objectives in-line with the goals of the functional area and drive the team to successful completion of all milestones.

  • Build systems and procedures for the transfer of analytical methods into QC including training plans, success metrics, and reporting policies.
  • Support the development, optimization and validation of analytical methods.
  • Qualify/transfer analytical methodology to/from quality control and contract laboratories.
  • Serve on and lead departmental and interdepartmental project teams.
  • Lead and/or participate in analytical investigations and engage subject matter experts as necessary.
  • Report and discuss analytical results and conclusions both orally and in writing.
  • Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
  • Review analytical data for completeness and correctness.
  • Adhere to all relevant compliance requirements.

Skills/Knowledge required:

  • Academic background in the Biological Sciences with demonstrated analytical capabilities.
  • Demonstrated technical ability in Flow Cytometry, ELISA, and PCR.
  • Experience managing teams and setting functional area objectives.
  • Experience supporting assay validation activities
  • Strong technical writing skills.
  • Strong problem-solving and troubleshooting skills.
  • Ability to work independently.
  • Strong verbal and written communication skills.
  • Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
  • Ability to provide scientific guidance, leadership and training to others within the department.

Skills/Knowledge in the following areas are a plus:

  • Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances.
  • Familiarity with the USP and other compendia.

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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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