R&D Specialist (Assay Development)

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:

R&D Specialists in the Assay Development Group (ADG) perform immunoassays under minimal supervision and troubleshoot assay-related problems with minimal assistance of his/her supervisor and may suggest modifications to protocols. They read literature related to project assignments and relevant regulatory documents.

Responsibilities:

• Designs and performs immunoassays (e.g., ELISA) under minimal supervision, based on protocols provided by supervisor and other scientists. Troubleshoots assay-related problems with minimal assistance of his/her supervisor. May suggest modifications to protocols. Assists with screening of reagents for use in immunoassay methods.

• Performs multiple assays within the same day.

• Reads literature related to project assignments. Reads relevant regulatory documents for ligand binding, biomarker and immunogenicity assays.

• May assist with evaluation of new technologies for the development of immunoassays using new formats or techniques.

• Interacts with peers and keeps supervisor informed on progress of work.

• Summarizes and presents results to supervisor in a logical manner, verbally and in written reports. Delivers presentations related to project assignments within department.

• Communicates effectively with supervisor and other personnel within ADG. May discuss reagent needs and/or services with outside vendors. May communicate with other groups within the company on specific projects.

• Writes assay validation protocols with minimal subsequent edits for review by supervisor and/or Study Director. Initiates planning of validation experiments and secures resources and reagents for validation. Performs validation experiments and summarizes results in a tabular manner. Drafts validation reports and bioanalytical method procedures (BMPs) for review by the Study Director.

• Performs Long Term Stability (LTS) testing for validated methods with minimal supervision. May update BMPs to incorporate LTS data.

• May train on validated bioanalytical methods with minimal supervision to perform sample analysis, if needed. May assist with training others within a team.

• Maintains GLP compliance for all laboratory work and documentation related to assay validations in accordance with FDA regulations and company SOPs. Assists in maintaining GLP compliance in the laboratory.

• May be responsible for the preparation of reagents and buffers for use within ADG, if needed.

• Maintains cleanliness of individual and communal work areas.

• Learns and complies with safety requirements of his/her laboratory. Recognizes potential safety problems and acts to correct them.

Educational Requirements:

• Bachelor's Degree (B.S.) in biology or a related field.

• Master's Degree (M.S.) is desirable.

Experience:

• A minimum of 5 years of post-degree laboratory experience for B.S. Degree.

• A minimum of 2 years of post-degree laboratory experience for M.S. Degree.
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.

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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.