Principal Scientist, Analytical Development (mRNA-LNP and AAV)

We are seeking a highly motivated Principal Scientist to support analytical strategy and method development within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. We are responsible for development, qualification and transfer of fit for purpose analytical methods that will be used to assess drug product stability of various genetic medicine products from discovery to pre-clinical/clinical development. In addition, this individual will support new analytical technology development and genetic medicine formulation characterization.

A day as a Principal Scientist looks like:

• Support analytical development for genetic medicine drug products, including AAV, mRNA-LNP and siRNA based therapeutics.
• Identify, develop and qualify fit-for-purpose analytical methods for product critical quality attributes to support formulation development, process development, and stability testing during preclinical and clinical stage. 
• Directly or indirectly leads, guides, and works with other Scientists and Research Associates in conducting research and developmental activities. Investigates and solves problems related to the methods used to assess product quality and stability. Sets goals, assigns tasks, and provides performance management and development as needed.
• Serves as an analytical team representative in cross functional team meetings, and shares knowledge and expertise within the company.
• Authors and reviews sections of regulatory and technical documents, method SOPs, method performance reports, method transfer documents and contributes to pharmaceutical development reports for completeness and correctness.
• Maintains full working knowledge of scientific literature for techniques and instruments and applying appropriately to projects.
• Identifies and assess novel analytical methods and technologies.  Contribute to the acquisition of new instrumentation.
• Demonstrates scientific excellence through reports, publications and patents.

This may be for you if:

• Track record in developing, troubleshooting, and validating analytical methods used in biopharmaceutical development.
• Knowledge and experience in analytical techniques used for biological product development including capillary electrophoresis (CE), HPLC/UPLC and mass spectrometry.
• In depth understanding and demonstrated expertise with analysis of AAV, mRNA-LNP and siRNA based therapeutics would be advantageous.
• Strong understanding of ICH guidelines and familiarity with analytical requirement for drug product development such as stability study, IV and SC administration is desirable.
• The ability to work independently to design experiments, as well as interpret, document and communicate results is required.
• Enthusiasm in science with a motivation for making contributions in a team environment is necessary.
• Demonstrated communication skills, collaborative attitude and strong multi-tasking capabilities to thrive in matrix teams.

To be considered, you must have a Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Science, Chemical or Biomedical Engineering with 3+ years industry experience or a BS +13+ years or a MS +10 years relevant experience developing and characterizing analytical methods for biological drug products.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$121,200.00 - $197,800.00