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Job Details

Staff Scientist Formulation Development

Location
Tarrytown, NY

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Position Summary

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 for a Staff Scientist to lead key Formulation and Product Development activities within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY.
The Staff Scientist in the Formulation Development Group (Tarrytown, NY) will be responsible for antibody based drug product formulation design and development in various stages of clinical and commercial development. In addition, the Staff Scientist will carry out research on protein formulation, protein stability and characterization, and develops new technologies.

Responsibilities

• Manage formulation development projects that include early and late stages of development.

• Leads formulation and product development and stability assessment activities that may include candidate screening and selection, developing lyophilized or liquid formulations for all phases of clinical and commercial development.

• Directly or indirectly leads, guides, and works with Research Associates in conducting research and developmental work, and investigating and solving developmental problems. Sets goals, assigns tasks, and provides performance management and development as needed.

• Serves as a team representative in drug development cross functional team meetings, and shares knowledge and expertise of formulations development within the company.

• Authors and reviews CMC sections of regulatory and technical documents, technical reports and technology transfer documents.

• Develops fit-for-purpose analytical methods to support formulation development and research stability testing.

• Leads or participates in general lab and instrument maintenance.

• May lead development of new formulation technologies and analytical technologies.

Requirements

• Ph.D. in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Science (or related discipline) with 4-7 years of relevant industry working experience.

• Working experiences in one or more of the following areas are required: protein formulation development for IV and SC administration, protein characterization and stability, IV admixture compatibility, biologics drug product process development, or antibody drug conjugate (ADC) development.

• Experience in drug product process technology transfer and working with contract research and/or manufacturing organization (CRO or CMO) is highly desirable.

• 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.

• Demonstrated track record of publications and patents.

• 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.

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