Quality Control Operations Scientist- Raw Materials

Location
Rensselaer, New York
Posted
Jan 25, 2022
Ref
REGEA0026R3678
Required Education
Doctorate/PHD/MD
Position Type
Full time

Regeneron is currently looking for a Quality Control (QC) Operations Scientist for our Raw Materials team with a Monday-Friday, 8am-4:30pm schedule. The QC Operations Scientist will provide support to the Quality Control Raw Materials group to ensure all testing and activities are in compliance with cGMPs and Regeneron’s internal procedures and policies.

           

As a QC Operations Scientist in the QC Raw Materials group, a typical day might include the following:

  • Representing QC Raw Materials with technical support for Deviations, including active participation in investigation, evaluation, and problem resolution
  • Providing technical support for sampling and laboratory activities, including evaluating current procedures and methods for improvement
  • Initiation and management of Change Controls, CAPAs, etc. for QC Raw Materials documentation and procedure creation and revisions
  • Supporting QC aspects for new and secondary-sourced raw materials to be used in manufacturing (method development, method validation, document creation/revision, etc.)
  • Reviewing analytical development reports, assay and process validation reports, and other technical documents for technical correctness and regulatory compliance
  • Writing technical documents, including technical justifications and method evaluations
  • Organizing and assisting with analytical method transfer, both internally and externally
  • Reviewing/editing Regeneron controlled documents
  • Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement and regulatory compliance

This role might be for you if you:

  • Have an understanding of regulatory and compendial requirements for cGMP manufacturing
  • Have an understanding of analytical testing procedures for chemical raw materials and utility systems
  • Are organized and have an attention to detail
  • Can prioritize multiple assignments and changing priorities in a fast-paced environment
  • Excel in a quality driven organization
  • Have an understanding of biologics manufacturing operations
  • Are able to learn and utilize computerized systems for daily performance of tasks
  • Have interest in or ability to mentor junior employees
  • Can work well within a team environment

To be considered for the QC Operations Scientist role, you must be willing and able to work Monday- Friday, 8am-4:30pm. You must have the following: Ph.D in Chemistry, Biology, Biochemistry, or related field; experience in the pharmaceutical and/or biotechnology field(s) is preferred. Level is determined based on qualifications relevant to the role.

Does this sound like you?  Apply now to take your first steps toward living the Regeneron Way!  We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!


Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.  We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.  Please contact us to discuss any accommodations you think you may need.

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