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QC Principal Scientist, Metrics

Req #: 1800885
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 Principal Scientist, Metrics

Summit, New Jersey

1.      Purpose and Scope of Position

The QC Principle Scientist, Metrics is responsible for maintaining all defined lab metrics . Additional responsibilities include, but are not limited to: designing and analyzing validation experiments, analysis and trending of stability data, EM Data, and all test method results.

2.      Required Competencies: Knowledge, Skills, and Abilities

  • Advanced ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
  • Fluency in statistical analysis and data visualization.
  • 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 ability to communicate effectively with peers, department management and cross- functional peers.

3.      Duties and Responsibilities

  • Collaborate with scientists to design assay validation experiments and analysis plans.
  • Prepare figures, tables, graphs, summaries, etc. and answer statistical based questions for reports and heath authority filings.
  • Prepare figures, tables, graphs, summaries, etc. for trend reports for stability, EM, and test methods.
  • Assist with the analysis of data from other Celgene QC laboratories and contract testing laboratories as required.
  • Provide data analysis support for process improvement projects.
  • Prepare reports for defined metrics and present to management.
  • Completes and reviews relevant sections of regulatory submission documents.
  • 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.

4.      Education and Experience

  • Requires a Bachelor’s Degree in in Statistics, Biostatistics, or related field.
  • Advanced Degree preferred.
  • 7-10 years of relevant work experience, preferable in a regulated environment.
  • Experience designing and analyzing validation experiments for laboratory assays.
  • An equivalent combination of education and experience may substitute.

5.      Working Conditions

  • The incumbent must analyze numerical values daily.
  • 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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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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