Principal Scientist, Biologics Drug Product Development (DPDT)

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Scientist to join our Drug Product Development & Technology (DPDT) team. You'll lead drug product development activities from candidate selection and pre-clinical development through clinical development and commercialization for a variety of drug modalities, including protein (antibody), siRNA, peptides, bioconjugates (antibody-oligo or antibody-drug), and AAV, across various drug and delivery presentations such as liquid and lyophilized drug products and novel drug delivery technologies.

Responsibilities

• Works independently to design and execute rigorous experiments in formulation, analytical, and process development, and technology transfer.
• Acts as a subject matter expert (SME) within their field, applying QbD approaches to drug product development and staying updated on regulatory guidelines.
• Uses scientific and statistical software (JMP or equivalent) to support study design and data analysis.
• Makes independent decisions of moderate complexity, employing a risk-based approach and knowing when to seek management feedback.
• Plans and leads complex, long-term projects, collaborating with cross-functional teams to ensure timely execution of deliverables.
• Proactively researches and implements new problem-solving approaches and process optimizations for product development and technology evaluations.
• Mentors and trains junior scientists in technical skills.
• Communicates technical data and recommendations effectively to varied internal and external audiences.
• Prepares data presentations, documents, publications, and patents.
• Maintains accurate laboratory records and complies with data integrity procedures and system requirements.
• Engages in lab and instrument maintenance, acting as an SME or team lead for new instrumentation and techniques.
• Compliers with environmental, health, and safety requirements.

Qualifications

• PhD in Pharmaceutical Sciences, Biochemistry, Chemistry, Biophysics, Biomedical or Chemical Engineering, or a related field with 4+ years of relevant industry experience.
• Alternatively, BS/MS with a minimum of 10 years of relevant industry experience.
• Industry experience with bioconjugates, particularly antibody-oligonucleotide formulation development, is preferred.

Skills

• Technical expertise in biochemical, biophysical, and/or microbiology principles.
• Proficiency in QbD approaches and regulatory guidelines.
• Experience with statistical software (JMP or equivalent) for study design and data analysis.
• Strong project management and cross-functional collaboration skills.
• Ability to mentor and develop junior scientists.
• Excellent communication and documentation skills.

Pay

Salary Range (annually) $128,600.00 - $210,000.00

Schedule

Full-time, standard business hours, with flexibility to support before- and after-hours executive meetings, town halls, and corporate events.

Location

On-site in Tarrytown, NY