Analytics Lead - Viral Vector Process Development


: $96,900.00 - $143,000.00 /year *

Employment Type

: Full-Time


: Healthcare - Allied Health

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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. Job Summary: The Preclinical Manufacturing and Process Development group is looking for an Analytical Lead, Process Development, responsible for establishing analytical efforts to support manufacturing process development functions. This function will provide Adeno-Associated Virus (AAV) manufacturing processes and products with the aim of providing treatment to unmet medical needs through gene therapy. The analytical function is embedded within the process development team and has the dual responsibility of designing, characterizing and implementing high through-put analytical tools supporting innovation of AAV manufacturing processes, while also performing routine analytical analysis. This is a growth opportunity that combines the excitement and opportunity of a start-up with the security and institution knowledge gained from working for a larger firm. Job Responsibilities include, but are not limited to: Support viral vector process development and production by designing, characterizing, implementing, coordinating, and executing fast and robust assays for the analysis of process- and product-related impurities of viral vector production processes. Lead assay development, drive results, and onboard new technologies. Demonstrate expertise in theory and practice of manufacturing steps and analytical methods. Cross-train on and provide support for upstream and downstream operations. 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. Sustain scientifically current (state of the art) laboratory environment and/or data systems 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. Knowledge of Design of Experiment (DOE) methodology for assay development. Working knowledge of viral biology preferred. Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and process development. Ability to think critically and demonstrate 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 is preferred: qPCR/ddPCR, ELISA-based assays, Analytical Ultracentrifuges, Western Blots and Gel Electrophoresis, HPLC, UPLC, Dynamic and Static Light Scattering, Hamilton Liquid Handlers, Chemical Fume hood, Empower, Unicorn, LIMS. Job Requirements: This position requires a Minimum of a PhD, and 0-5 years' relevant experience, or MSc/BSc with 5years of relevant experience. Preferred experience would include: ? An understanding of assay development within the biopharmaceutical industry. ? 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. ? Prior experience with viral vector-based gene therapies is a plus. Supervisory Responsibilities: Initially this position will be responsible for directly managing one to two direct reports, with the strong potential for future growth. Therefore, the ability to critically select and motivate talent, and coach Process Development Engineers and Associates in conducting research and development, analyzing results and documenting findings, will be important. 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.
Associated topics: blood collection, hematopathology, medical, medical lab science, microbiology, pathology, sterile processing technician, surgical technologist, technician, technician iv * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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