Staff Engineer - Viral Production Core - Analytics

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.

Summary
The Preclinical Manufacturing and Process Development group is looking for a Staff Engineer/Senior Staff Engineer, responsible for establishing and leading our Viral Production Core (VPC) analytical group to support process development functions. This function will provide Adeno-Associated Virus (AAV) manufacturing processes and products supporting Regeneron's Discovery and R&D efforts. These AAV will be used for a variety of applications including pharmacologic characterization of our AAV-based gene therapy products, ultimately destined for clinical studies, as well as AAV materials for clinically enabling toxicology studies.

Responsibilities include, but are not limited to:

• Support viral vector process development and production by designing, coordinating, and executing fast, well-characterized and robust assays for the analysis of process- and product-related impurities of viral vectors.

• Lead assay development, drive results, and onboard new technologies.

• Demonstrate expertise in theory and practice of manufacturing steps and analytical methods.

• Provide lab-based support for upstream and downstream operations as needed.

• Maintain scientifically current (state of the art) laboratory environment and/or data systems.

• Prepare and deliver effective oral presentations in area of expertise at internal and external professional meetings with minimal consultation with supervisor. Share cross-functional skills and knowledge at a wide variety of meetings. Write complete internal and/or external "publications" that require minimal revisions (i.e., Process transmittals, development reports, patents, Peer Reviewed publications etc.).

• Participate in operational collaborations with Regeneron groups or academic collaborators; build cross departmental gene therapy expertise across Regeneron via collaboration and pro-active leadership.

• Drive continuous improvement, and perform long term planning for laboratory related personnel, supplies and equipment.

Required Skills:

• Designs and develops analytical techniques for characterization of viral vector products.

• Expert in Design of Experiment (DOE) methodology for assay development.

• Working knowledge of the demands of GMP manufacturing.

• Working knowledge of viral biology.

• Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and process development.

• Ability to think critically and demonstrated troubleshooting and problem solving skills.

• Excellent interpersonal, verbal and written communication skills.

• Ability to function efficiently and independently in a changing environment.

• Ability to read, analyze, and interpret common scientific journals.

• Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.

• Ability to operate the following equipment:

ELISA-based assays, Analytical Ultracentrifuges, Western Blots and Gel Electrophoresis, qPCR/ddPCR, HPLC, UPLC, Dynamic and Static Light Scattering, Chemical Fume hood, Empower, Unicorn, LIMS.

Supervisory Responsibilities:

Critically select and motivate talent. Directly or indirectly lead, guide, and assist Process Development Engineers and Associates in conducting research and development, analyzing results and documenting findings. Set goals, assign tasks, provide performance management and development. Delegate both routine and important tasks, providing direction as appropriate.

Requirements:
This position requires a Minimum of a PhD, and 3 - 7+ years relevant experience, or MSc with 8+years of experience. Experience should include:

• An in-depth understanding of assay development within the biopharmaceutical industry, as well as significant experience applying this toward development of manufacturing processes of biotherapeutics.

• A thorough understanding of statistical analysis principles used in Design of Experiments to efficiently, optimize and characterize assays to provide statistically meaningful outputs and direction for future studies and final processes.

• Experience in successful technology transfer of assays to GMP Manufacturing facilities.

• Well versed in current Regulatory Requirements for AAV-based gene therapy products.

• History of assay development in the biotechnology industry.

• Prior experience with AAV-based gene therapies is a plus.

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.