Scientist (Analytical Method Deveolpment)

Location
Tarrytown, NY, United States
Posted
Mar 25, 2019
Ref
15685BR
Required Education
Associate Degree
Position Type
Full time
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.

Summary
We are seeking a Scientist/Staff Scientist to support key analytical method development and method characterization activities within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY.

The Scientist/Staff Scientist in the Formulation Development Group (Tarrytown, NY) will be responsible for development of fit for purpose analytical methods that will be used to assess purity and stability of antibody based drug product formulations and drug product images at various stages of clinical and commercial development. In addition, this individual will carry out research on protein formulation, protein stability, protein characterization, and new analytical technologies.

Responsibilities

• Develops and qualifies analytical methods to support formulation development, process development, and research 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.

• Identifies and assess novel analytical methods and technologies. Contribute to the acquisition of new instrumentation.

• Participates in general lab and instrument maintenance.

Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Science, Chemical or Biomedical Engineering (or related discipline) with a minimum of 1-4 years relevant experience in developing analytical methods for biological drug products and/or characterizing biological drug products.

• Track record in developing, trouble-shooting and validating separation methods (e.g. CE, HPLC/UPLC).

• Knowledge and experience in protein stability characterization, degradation pathway identification and particle analysis using biochemical and biophysical tools.

• Good understanding of ICH guidelines and familiar with analytical requirement for drug product development such as stability study, IV and SC administration is desirable.

• Hands-on experience and trouble-shooting proficiency with biophysical techniques (DLS, CD, FTIR, DSC, AUC, Fluorescence, Raman spectroscopy, etc.) for protein characterization are a plus.

• Familiarity with the techniques commonly used to identify and quantitate leachable and extractable compounds in biologic drug products would be advantageous.

• Experience with quality by design (QbD) or the application of statistical approaches to method development including design of experiments (DOE) is highly desirable.

• The ability to work independently to design experiments, as well as interpret, document and communicate results is required.

• Excellent oral and written communication skills are required.

• Enthusiasm in science with a motivation for making contributions in a team environment is necessary.

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.