Regeneron Analytical Specialist-Bioassay – Candidates Apply Online
Regeneron is currently looking for an Analytical Specialist position with a 1st shift, Tuesday-Saturday, 8 am-4:30 pm schedule. This position is part of the Analytical Sciences Bioassay Method Development 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 products through Process Validation. This position will be responsible for the development and troubleshooting of cell-based assays and binding assays utilized in Quality Control testing. The Bioassay Development team employs a functional model where a portion of the group is devoted to binding assay development and another portion of the group is devoted to cell-based development. In this fast-paced environment with a strong pipeline, Analytical Specialists have the opportunity to develop scientifically but also gain insight into other areas of the business.
Job Title: Analytical Specialist-Bioassay Development (1st shift, Tues-Sat)
Location Rensselaer, New York, United States of America CategoryIndustrial Operations and Product Supply
Job Id R2586
As an Analytical Specialist, a typical day might include the following:
- Work cross-functionally to bring new assays into the group from our research groups.
- Design and execute assay development experiments to deliver robust assays.
Utilize statistical Design of Experiments to streamline assay development.
- Perform statistical analysis of data to understand trends and identify next steps in assay development.
- Work closely with clinical and commercial Quality Control testing groups to support assay troubleshooting.
- Create test method documents that will be used in routine clinical release and stability testing.
- Draft technical reports to summarize development and assay qualification studies.
Identify and evaluate new technology for use in the Quality Control testing laboratories.
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 them and execute them independently, while excelling at keeping all impacted parties well advised.
- 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) and Softmax.
- Understand working with statistical software such as JMP.
- Enjoy developing novel assays with little initial guidance.
- Have development experience in cell-based potency assays or ELISA.
- Have experience with developing and troubleshooting potency assays for testing in a GMP environment.
- You must have a BS/BA in Biology, Biochemistry, Cell Biology or related field; Cell Biology, Biology or Biochemistry preferred. For the various levels you must have the following:
- Associate Analytical Specialist: BS/BA in Life Sciences, or related field and 0-2 years of relevant experience; or an equivalent combination of education and experience
- Analytical Specialist: BS/BA in Life Sciences, or related field and 2+ years of relevant experience; or an equivalent combination of education and experience
- Senior Analytical Specialist I: BS/BA in Life Sciences, or related field and 4+ years of relevant experience; or an equivalent combination of education and experience
- Experience with binding assays, cell-based potency assays and ELISA testing preferred. The level is determined based on qualifications relevant to the role.
Regeneron Analytical Specialist-Bioassay