Process Development Engineer Purification Development

Location
Tarrytown, New York, US
Posted
Jul 13, 2018
Ref
12876BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary

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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

We are seeking a process development engineer who enjoys working on projects collaboratively and is also capable of recognizing when someone needs to take the lead, and is equally comfortable doing so. This role is a hands-on junior management position within the Purification Development group within Preclinical Manufacturing and Process Development (PMPD). This engineer will be involved in the full scope of the department's work supporting our robust pipeline from preclinical evaluation all the way through commercial licensure and life cycle management of the processes providing important medications to our patients with unmet medical needs. This position includes leading and performing Quality by Design (QbD) driven, state of the art downstream process development, based on Regeneron's suite of proprietary technologies. This engineer will be relied upon to support technology transfer of these processes to our GMP manufacturing facilities around the world. This position will also have a highly visible role within the department while driving the group's technical development priorities forward. This individual would be entrusted with the career development of junior engineers and would be given the resources, time and training to effectively mentor and develop them. The ideal candidate would not only be an effective leader of their own subgroup, but be willing to be a non-positional leader within their larger group.

Responsibilities:

• Development of Innovative Polishing chromatography separations, within a cross functional team of other SME's to deliver a final process that has been prospectively developed using the principals of QbD to ensure robust, uninterrupted supply of safe medicines for our patients.

• Utilizes subject matter expertise in field of chromatography to design, lead, and react to experiments/projects independently.

• Experienced leader that knows when and how to delegates tasks, inspires individuals whether direct reports or project team members, and demonstrates strong leadership and poise in approach to their work and the management of their group.

• Analyzes data and interprets experimental results within context of "project" goals and makes recommendations to management. Use of statistics, such as ANOVA, nonlinear least square regression, and well-designed DoE's, etc. to characterize design space and generate statistical models of process performance, variation and failure rate.

• Communication with all levels in the organization, demonstrating meticulous organization and high attention to detail. Conduct research and development in area of subject matter expertise with minimal guidance. Makes Science-based recommendations by novel incorporation of learning from internal and external (literature) sources.

• Potential additional responsibilities include participation in viral clearance studies for clinical and commercial drug candidates and process transfer to Regeneron's manufacturing facilities. The position may require travel (5-10%) and occasional work on weekends.

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Requirements:
The ideal candidate will have a degree in Chemical Engineering or Biochemical Engineering.
PhD. 0-2 years of experience, M.S.c with 5-7 years' experience, or B.Sc. with 8-10 years of experience.

Relevant experience with:
Akta Explorer/Avant, Akta Pilot, BioProcess Skid, Depth Filtration, Tangential Flow Filters, Normal Flow Filters, Chromatographic Columns, HPLC, UPLC, Diafiltration Skid , Laminar Flow Hood, Chemical Fume Hood, Empower, Unicorn, JMP, LlMS, Tech Transfer Experience to GMP Manufacturing. Small Scale Purification Model Development.

Level will be commensurate with 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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.