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: Perform characterization of drug product container and closure systems to fully establish compatibility for storage, use, and integration into delivery devices. Investigate new technology development for packaging of finished dosage forms. Maintain and control primary container-related information and documentation per project design control requirements.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Perform characterization of container closure systems though laboratory testing and analysis, including prefillable syringes, cartridges and vials.
* Author and control documentation for drug product primary container design inputs requirements in accord with principles of design control.
* Participate in container and closure manufacturing process improvement efforts and investigations at vendors.
* Proposes novel testing and manufacturing methods in order to advance available technologies and gain value in intellectual property.
* Ensure containers and closures and well understood in terms of materials and mechanical performance before attempted integration into delivery device design.
* Propose novel testing and manufacturing methods in order to advance available technologies and gain value in intellectual property.
* Provide technical consultation to internal and external groups and business partners to support projects and investigations.
* Monitor changing regulatory requirements, industry standards, and best practices for container closures and integration with delivery devices. Ensure developments are communicated within External Manufacturing Dept. and appropriately implemented.
* Maintain required training status on Regeneron specific work instructions and SOPs.
* Travel to manufacturers or business partners, as required.
Knowledge and Skills:
* Medical Device Design Control.
* Statistical analysis techniques.
* Technical writing.
* Lab experience with knowledge of instrumental measurement techniques.
* Knowledge of industrial glass forming and rubber molding/trimming preferred.
* BS/BA in engineering required, along with 3 years of industry experience, or MS with 2 years of 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.