Job description

Within this role you will perform a variety of activities to support release, stability, in-process and final drug product programs.

As a QC Data Analyst a typical day might include, but is not limited to, the following:

  • Compiling internally and externally generated data in support of compiling CofAs and SofAs
  • Preparing and providing CofAs and SofAs for all lot release materials
  • Working with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues, etc.
  • Trending QC product release data to support lot release and regulatory filings
  • Acting as a liaison between QC, Process Analytical Sciences, and Manufacturing group to provide trending analyses to support various activities such as manufacturing investigations, and validation studies
  • Assisting in the implementation and maintenance of product release data trending program for each product candidate
  • Presenting trending data at the in-depth product review
  • Writing product annual release data trending reports
  • Writing lot specific data trending reports for each lot to be released
  • Preparing and populating matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
  • Compiling data to support QC department metrics and performance tracking
  • Assisting with the improvement effort of streamlining the review and release process
  • Attending meetings as required on behalf of Quality Control to update partners (Drug Supply, External Manufacturing, QA) as to status issues pertaining to release data
  • Attending meetings to keep informed of development and manufacturing priorities and activities
  • Ensuring compliance with applicable cGMP regulations and SOPs
  • Maintaining and updating relevant SOPs for data review and reporting as needed
  • Meeting specified timelines to support release and regulatory filings
  • Compiling with all pertinent regulatory agency requirements
  • Participating in required training activities

To be considered for this opportunity you must hold a BS/BA in Chemistry, Biology or related field. 2 years of experience working in a cGMP pharmaceutical Quality Control Laboratory .Or equivalent combination of education and experience.

#IRELIM #JOBSIEST #REGNQC

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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