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 commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Manage investigation of process variances involving aseptic filling, container closure materials and manufacturing, and delivery device performance and manufacturing.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Management of deviations encountered during aseptic filling at contract manufacturers.
* Management of deviations encountered as a result of inconsistencies in primary container and closure manufacture.
* Management of deviations encountered as a result of inconsistencies in delivery device performance and manufacture.
* Provide technical leadership to internal and external groups in order to complete deviation investigations and disposition of supply.
* Maintain strict adherence to quality system metrics targets and cycle time goals.
* Propose standardization and business process improvements in order to increase efficiency and timeliness deviation investigation closure.
* Provide regulatory filing support for drug product (IND, BLA, MAA, etc.) as well as support during regulatory inspection of site quality systems.
* Monitor changing regulatory requirements, industry standards, and best practices for filling, delivery devices, and packaging. Ensure developments are communicated within the company and appropriately implemented.
* Technical liaison between Regeneron Quality Control, Quality Assurance, Operations/Logistics Departments and contract manufacturers or business partners.
* Maintain required training status for staff on Regeneron specific work instructions and SOPs.
* Travel to manufacturers or business partners, as required.
* BS/BA in engineering, materials science, physical or biological sciences or business with 4 years industry experience. MS with 3 years industry experience.
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 agencies: 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 will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.