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.
The Scientist/Staff Scientist in the Formulation Development Group (Tarrytown, NY) is responsible for antibody based drug product design and development in various stages. The Scientist carries out research on protein drug delivery (i.e. controlled or sustained release, delivery devices) and drug targeting for parenteral and enteral routes of administration, protein formulation, protein stability and characterization, and new technology development for high concentration product development.
• Leads and participates in formulation and product development and stability assessment activities that may include candidate screening and selection, developing lyophilized, spray dried, or liquid formulations for preclinical evaluation, clinical studies and commercialization.
• Responsible for identifying, evaluating, and developing novel delivery systems (i.e. controlled or sustained release) and device technologies suitable for protein, peptide, or nucleic acid delivery (i.e. combination products)
• Develops fit-for-purpose analytical methods to support formulation and process development and research stability testing
• Independently designs stability studies and in vitro experiments to understand quality attributes to support formulation development and optimization. Primarily responsible for executing experiments at the bench, performing subsequent data analysis, and documenting all work in electronic notebooks.
• Presents work at group, department and cross functional meetings, serves as a team representative in drug development team meetings, and shares knowledge and expertise of formulations development at cross-functional team meetings
• Authors and reviews formulation development sections of regulatory and technical documents, study reports and technology transfer documents
• Participates in general lab and instrument maintenance
• Adept at learning about and assessing new technologies in formulation, devices, and analytical methods
• Able to handle multiple tasks while meeting timelines and adapting to changing priorities
• Ph.D. in Chemistry, Biochemistry, Pharmaceutical Science, Chemical or Biomedical Engineering (or related discipline), Materials Science with 0-7 years of relevant industry experience, and a proven track record of publications in the field. Post-doctoral experience is preferred but not a requirement.
• Must have experience with controlled release delivery systems, such as micro/nanoparticles, hydrogels, polymers, liposomes, devices, etc., and preferably with proteins, peptides, or RNA/DNA.
• Experience in spray drying, microfluidics, particle engineering, or polymer synthesis and characterization is highly desirable
• Background in combination device development or mechanical engineering is preferred
• Excellent oral and written communication skills are required.
• Demonstrated track record of publications or patents
• Must be detail oriented, be able to recognize subtle trends in data, good problem solving abilities, and possess an ability to grasp the big picture.
• Enthusiasm in science with a motivation for making contributions in a team environment is necessary.
• Background in protein characterization, protein stability, analytical method development, admixture compatibility study, lab automation and parental drug product process development is highly desirable.
• Hands-on experience and trouble-shooting proficiency with applying chromatographic (HPLC, UPLC, column chromatography), capillary electrophoresis and/or biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, Raman spectroscopy, particle analysis, GPC, etc.) for protein characterization are plus.
• Experience applying QbD principles to analytical method, process, and product development