Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
- Responsible for all QC data reporting activities associated product release.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Oversee and participate in the generation of Certificates of Analysis (CofA) and Summaries of Analysis (SofA) for all lot release materials
- Compile internally and externally generated data in support of CofA / SofA generation
- Work with members of manufacturing, QA, RA, and Project Management to provide updates/status of CofAs, SofAs, testing related issues, potential lot release issues, etc.
- Prepare and populate matrices (databases, spreadsheets) designed to track testing and review status of lot release samples, stability samples, etc.
- Oversee accessioning and filing of release, in-process, and stability data
- Compile data to support QC department metrics and performance tracking
- Assist with the improvement effort of streamlining the product release process
- Attend meetings as required on behalf of Quality Control to update partners (Drug Supply, External Manufacturing, QA) as to status of QC lot release testing, CofA / SofA generation, etc.
- Serve as primary QC point of contact for issues related to testing status, lot release priorities, CofA status, etc.
- Attend meetings to keep informed of development and manufacturing priorities and activities
- Ensures compliance with applicable cGMP regulations and SOPs
- Maintain and update relevant SOPs for data reporting as needed
- Complies with all pertinent regulatory agency requirements.
- Participates in required training activities.
Education and Experience:
- Requires BS/BA in Chemistry, Biology or related field as well as 5 + years experience working in a cGMP pharmaceutical Quality Control Laboratory (preferred). - May substitute other relevant experience. Excellent written and verbal communication skills and attention to details are a must. Knowledge of lab information management system (LIMS) is required. Supervisory or team / project lead experience preferred (but not required).
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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