If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
Support the Quality Control (QC) and Process Sciences (PS) departments by maintaining their laboratory instrumentation in an operational, qualified state. This entails ensuring both instrument hardware and software qualifications are completed in a timely manner and keeping them in a qualified state.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Function as super user for the Empower 2 chromatography data server. In this capacity, assist analysts in troubleshooting issues and creating custom calculations and processing methods.
- Establish best in class IQ/OQ/PQ processes and execution for laboratory instrumentation
- Develop and write protocols for instrument qualification/validation studies.
- Assist in performing instrument qualification/validation experiments.
- Help troubleshoot instrument performance issues.
- Work with the vendor to schedule and complete necessary repairs.
- Complete instrument related MC documents on behalf of QC.
- Collaborate with Engineering department to ensure equipment
calibrations are completed.
- Construct instrument interface with LIMS.
- Develop a working knowledge of all software platforms in QC and troubleshoot them as necessary - for example Empower.
- Tabulate results and write summary reports of instrument and software uses and qualification studies.
- Help to organize the new instrument evaluation and purchase activity.
- Present status updates at group and possibly at interdepartmental meetings.
- Produce and maintain accurate and GMP compliant records.
- Write SOPs relevant to laboratory instrument and software operation.
- May perform routine quality control in-process, release, and stability testing, as needed.
Education and Experience:
- Requires BS/BA in Chemistry or Biology; may consider another degree discipline or position level with commensurate experience; cGMP experience is also required. - Experience with executing IQ/OQ/PQ protocols and administering software databases is highly desirable.
- Working knowledge of change control in the pharmaceutical industry is a plus.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits.
Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com
ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.
To apply for this position, please CLICK HERE