Scientist/Staff Scientist, Analytical Formulation Development
Tarrytown, New York, United States
Job type: fulltime
Job industry: Science & Technology
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.
We are seeking a Scientist/Staff Scientist to support key analytical method development and method characterization activities that will support Formulation and Drug Product Development 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.
- Develops and qualifies fit-for-purpose analytical methods to support formulation development, process development, and research stability testing for programs that include early and late stages of development.
- 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 assesses novel analytical methods and technologies. Contributes to the acquisition of new instrumentation.
- Participates in general lab and instrument maintenance.
- Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Science, Chemical or Biomedical Engineering (or related discipline) with relevant experience in developing analytical methods for biological drug products and/or characterizing biological drug products. Strong applicants at all levels are encouraged to apply.
- Experience in one or more of the following areas is required: characterization and forced degradation of recombinant monoclonal antibodies and/or other protein therapeutics which may include antibody drug conjugates, biologics drug product process development, or protein formulation development for IV and SC administration.
- Extensive practical expertise and trouble-shooting proficiency in high-performance liquid chromatography (HPLC/UPLC), capillary electrophoresis (CE), and the techniques and methods commonly used to characterize sub-visible particles in biological drug products.
- Track record in method development and validation of CE or HPLC based methods; experience with method transfer and good understanding of ICH validation guideline are highly desired.
- Knowledge and experience with protein characterization using MS 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 independently to design experiments, as well as interpret, document and communicate results is required.
- Must excel when working in a fast-paced environment and be able to manage multiple projects and competing priorities.
- Excellent oral and written communication skills are required including the ability to use standard business software like Microsoft Office.
- Enthusiasm for science and motivation for making contributions in a team environment is necessary.
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.