Staff Scientist Formulations Development

Profile

Our Formulations Development Group (FDG) is looking for an enthusiastic Staff Scientist to work on the development of drug product formulations for a diverse set of modalities such as mAbs, mAb-like proteins, siRNA, AAV, and/or Lipid Nanoparticles (LNP).

A Staff Scientist in FDG leads and participates in drug product development and stability assessment activities that may include candidate screening and selection for preclinical and Phase 1 clinical studies, and developing formulations for Phase 2/3 clinical studies and commercialization. This includes assessment and selection of primary container closure system such as pre-filled syringes.

A typical day in this role might look like:

• Directly manages or indirectly guides 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.
• Independently design, write, execute and document stability studies and other experiments to support stability testing and understand quality attributes to support formulations and stability
• Develops and use analytical methods to support formulation development & stability testing of mAbs, siRNA, AAV, LNP, and other modalities.
• Seeks out, recognizes and assesses new technologies to improve formulation development and analytical characterization
• Presents work at group, department and inter-department 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
• Collects, processes and documents data by following the organizational best practices and policies.
• Applies statistical knowledge and software packages (e.g. JMP) for study design and data analysis.
• Keeps updated on scientific findings by reading peer-reviewed science journals, and attending and presenting at relevant scientific conferences.

This role may be for you if:

• You have a passion for science with a motivation for making contributions and thrive in a creative, flexible team environment.
• Excellent verbal and written communication skills, with a proven track record.
• Ability to quickly adapt to changes in program direction and are inquisitive to take new ideas and tackle on technical challenges.

You have Ph.D. in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Biomedical Engineering, Chemical Engineering, or a related discipline with 2-5 years post-doctoral or industry experience. Proficient in protein and/or gene therapy research and characterization, with keen analytical and problem-solving skills.

• Hands-on experience with proteins (mAb, mAb-like proteins) and viral/non-viral gene therapy modalities (siRNA, LNP, AAV, etc.).
• Strong technical knowledge base and proven experience with protein/peptide/nucleic acid chemistry, biophysical/biochemical characterization of proteins and gene vectors, bioanalytical method development and biomolecule product development.
• Prior experience with chromatography methods (HPLC, UPLC, column chromatography), visible and subvisible particle analysis, capillary electrophoresis and/or biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, Raman spectroscopy) for protein/gene vector characterization.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

,identifier:{name:**MEMBERS ONLY**SIGN UP NOW***.,value:REGEA0026R9238,@type:PropertyValue},datePosted:2022-03-01T03:18:51 00:00,validThrough:2022-03-31T03:59:59 00:00,employmentType:FULL_TIME,hiringOrganization:{name:**MEMBERS ONLY**SIGN UP NOW***.,@id:395032,url:****New York,address:{addressCountry:US,addressLocality:New York,addressRegion:New York,postalCode:10591,@type:PostalAddress},@type:place},industry:Science/R&D, Biotechnology,workHours:Full time,educationRequirements:Associate Degree,@type:JobPosting,@context:****

Company info

Sign Up Now - ScientistCrossing.com