Staff Engineer - Viral Production Core - Upstream

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) upstream process development group. The VPC 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:

• Design, coordinate, and execute optimized, characterized and robust seed train and bioreactor processes for the upstream production of viral vectors suitable for future GMP clinical production.

• Develop protocols for vector production in suspension cell lines.

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

• Support laboratory downstream operations and analytical development and testing as needed.

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

• 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.

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

Required Skills:

• Designs and develops novel upstream technologies to apply to bioprocesses. Implement and/or develop innovative vector production technologies based on Quality by Design strategies.

• Mathematical modeling of bioprocesses, process simulation, and/or cost of goods modeling.

• Expert in Design of Experiment (DOE) methodology.

• Plans process translation and scale-up from manual upstream methods to automated platforms featuring single-use systems.

• 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.

• Knowledge of viral and adventitious agent control and safety evaluation.

• Ability to operate the following equipment:

NOVA FLEX, NOVA CDV, Bench top disposable bioreactor, Single-use bioreactors (50-500 L), Biosafety cabinets, incubators, autoclave, Rockwell RSView32, Finesse TruBio, Pi Historian, JMP, 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.

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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 engineering principles and experimental design, 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 plan process development, optimization and characterization studies to provide statistically meaningful outputs and direction for future studies and final processes.

• Substantial experience in successful technology transfer of biotherapeutics to GMP Manufacturing facilities.

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

• History of developing upstream steps within bioprocesses.

• Prior experience with producing 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.