Scientist/Staff Scientist, 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 formulation and drug product process development activities within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY.
The scientist will be responsible for developing formulations for antibody-based drug products, drug product process development and analytical method development to support various stages of clinical development and commercialization. This is a cross functional role which supports research, pre-clinical, clinical and manufacturing teams whose primary function is to move drugs from candidate selection and preclinical development through clinical development to commercialization. In addition to extensively interacting with cross functional teams, individuals are responsible for carrying out and overseeing protein formulation development and stability testing of lyophilized and liquid formulations. Scientists will also carry out research on protein stability and characterization, analytical method development and new technology identification and implementation.
- Responsible for all aspects of formulation and drug product process development projects that include early and late stages of development.
- Conducts biophysical/physicochemical characterization, pre-formulation activities and selection of preclinical antibody candidates.
- Develops fit for purpose analytical methods to support formulation development, process development, and research stability testing.
- Directly or indirectly leads, guides, and works with research associates and other scientists in conducting research and developmental work, and investigating and solving development problems.
- Sets goals, assigns tasks, and provides performance management and career development as needed.
- Serves as a team representative and subject matter expert in drug development cross functional team meetings, and shares knowledge and expertise of formulations development within the company.
- Authors and reviews formulation development sections of regulatory and technical documents, study reports and technology transfer documents.
- Participates in general lab and instrument maintenance.
- Ph.D. in Chemistry, Biochemistry, Pharmaceutical Science or related discipline with relevant protein experience and a track record of publications in quality peer-reviewed journals and conference presentations. Consideration at the Staff Scientist level requires experience in formulation development of biologic drug products and/or characterization of biologic drug products. Post-doctoral experience is preferred but not required.
- Expertise in protein chemistry/biochemistry and characterization, with keen analytical and problem-solving skills are a must. Expertise in protein stability, structure or biophysics is highly desirable.
- The ability to independently design and execute experiments, as well as interpret, document and communicate results is required.
- Experience with quality by design (QbD) or the application of statistical approaches to formulation or analytical method development including design of experiments (DoE) is highly desirable. Experience with statistical analysis software (such as JMP) is a plus.
- Hands-on experience and trouble-shooting proficiency with applying chromatographic (HPLC, UPLC, column chromatography) methods, capillary electrophoresis and/or biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, Raman spectroscopy, particle analysis, etc.) for protein characterization are plus.
- 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 are necessary.
- Must excel when working in a fast-paced environment and be able to manage multiple projects and competing priorities.
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.