Scientist, Analytical Formulation Development

Location
Tarrytown, New York, United States of America
Posted
May 21, 2021
Ref
24857BR
Required Education
Associate Degree
Position Type
Full time
We are seeking a Scientist to support key analytical method development and method characterization activities within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. In this role, you will be responsible for developing fit for purpose analytical methods that will be used to assess drug product stability of various modalities, including mABs, ADC, fusion proteins, RNA therapeutics from pre-clinical to commercialization development. In addition, this individual will support development of new analytical technologies/tools for assessing formulation and stability characterization.

A Typical Day in the Role Might Look Like:
• Develops and qualifies analytical methods to support formulation development, process development, and stability testing for early and late stages programs.
• 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 proven understanding 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.
• Participates in general lab and instrument maintenance.

This Role Might Be For You If:
• You have strong initiative and drive to complete results-oriented tasks and learn new technologies related to formulation development.
• You are capable of multi-tasking, working both independently and within a team environment.

This role requires a Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Science, Chemical or Biomedical Engineering (or related field) with a minimum of 1-4 years meaningful experience in developing and characterizing analytical methods for biological drug products, including mABs, ADC, fusion proteins, RNA therapeutics. Track record in developing, trouble-shooting and validating analytical methods used in biopharmaceutical development, including capillary electrophoresis, HPLC/UPLC, mass spectrometry. Strong understanding of ICH guidelines and familiar with analytical requirement for drug product development such as stability study, IV and SC administration is desirable. Knowledge and experience in protein characterization, degradation pathway identification and particle analysis for biological products using biochemical and biophysical tools are a plus. Familiarity with the techniques commonly used to identify and quantitate leachable and extractable compounds in biologic drug products would be advantageous. The ability to work independently to design experiments, as well as interpret, document and communicate results is required. Experience with quality by design (QbD) or the application of statistical approaches to method development including design of experiments (DOE) is desirable. Excellent oral and written communication skills are required. Enthusiasm in science with a drive for making meaningful contributions a plus.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.