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.
Jointly and independently work on various Quality Control projects for their design, monitoring, tracking, reporting, problem identification and solving.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Help to design and start QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
- Co-author and maintain various departmental business report (e.g., report-card, productivity matrix)
- Track and monitor timeline of analytical and development and validation projects.
- Monitor the departmental performance matrix for NOE/EOE/DNF/CAPA/WF/Training/OOS/Invalid/Other critical Items
- Design, organized, track and facilitate department continuous improvement events.
- Help to design, monitoring, improve and report of departmental training program.
- Help to monitor the critical supplies of commercial testing.
- Participate in and facilitate the communication of QC with its contract labs
- Help to achieving critical QC documents (e.g., assay development and validation history and spec development workbook) and their migration to Qumas or other cooperate database when needed.
- Special projects as assigned.
Education and Experience:
- BS in chemistry, biology or related field with 2+ year experience in laboratory operation or project management. Strong administrative experience and proven technical writing skills.
- Excellent communication skills with approved ability to work in cross-functional teams. Strong computer skills in microsoft Excel including use of macros, pivot tables to analyze complex data and other office software. Working experience with various statistical software. Any visual management and presentation skill is strong 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