Regeneron is currently looking for an Analytical Development Specialist position with a 1st shift, Tuesday-Saturday, 8am-4:30pm schedule. This technical lead position is part of the Analytical Sciences Material Identification Team. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product through Process Validation. This position will be responsible for identifying unknown material observed at IOPS. In this fast pace environment with a strong pipeline, Analytical Development Specialists have the opportunity to develop scientifically but also gain insight into other areas of the business.

As an Analytical Development Specialist, a typical day might include the following:

• Execute investigation testing for the chemical identification of unknown material for manufacturing, process sciences or quality control support.
• Provide oversight and scientific guidance within the laboratory and to direct team members.
• Evaluate/interrupt data and co-author memos for investigational testing.
• Establish, develop, and/or optimize analytical methodology for the analysis of unknown compounds/contaminates/debris. At times in varying matrices or particle size.
• Assist in the analysis of samples generated from lab scale process studies.
• Assist in product failure or customer complaint investigations.
• Tabulate results and write summary reports of assay development and validation studies.
• Present findings at group and interdepartmental meetings.
• Produce and maintain accurate records.

This role might be for you if you:

• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple projects, prioritize and execute them independently, while excelling at keeping all impacted parties well advised.
• Enjoy a dynamic day-to-day and provide guidance technical leadership within the team.
• Can take on new and sometimes ambiguous challenges and learning quickly.
• Are able to work in a team environment but can also take ownership of large technical reports and projects.
• Develop and drive scientific and/or business-related improvement ideas.
• Enjoy statistical analysis of data to support theories.
• Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint,etc) and Waters, Agilent, or equivalent chromatographic softwares.
• Understand working with statistical software such as JMP.
• Enjoy developing novel assays with little initial guidance.
• Have development experience in chromatography and/or spectrometric-based assays.
• Have experience with developing and troubleshooting chemical assays for testing in a GMP environment.
• Have excellent fine motor skills

To be considered for the Analytical Specialist position you must be willing and able to work Tuesday-Saturday, 8am-4:30pm. You must have a BS/BA in Biochemistry, Chemistry, or related field. For the various levels you must have the following:

Analytical Specialist: BS/BA, or related field and 2 years of relevant experience; or an equivalent combination of education and experience

Senior Analytical Specialist I: BS/BA, or related field and 4 years of relevant experience; or an equivalent combination of education and experience

Level is determined based on qualifications relevant to the role.