Regeneron is seeking an Analytical Scientist specializing in Cell and Gene Therapy (CGT) programs. This position is part of our Quality Control (QC) Analytical Sciences Development team. The Analytical Scientist serves as a subject matter expert and leader in the lab, you will work closely with our Research and Development teams to support the Manufacturing, Process Sciences (PS), QC, and CRO/CDMO partners through the development, optimization, characterization, qualification, and transfer of analytical methods across a wide range of novel modalities for Regeneron CGT programs.

As an Analytical Scientist , a typical day might include the following:

• Collaborate with partner groups in research to bring in-house, develop, and optimize analytical methods to evaluate novel CGT candidates using analytical methods such as digital PCR, ELISA, electrophoresis, HPLC, and cell-based methods for eventual transfer to GMP testing groups.
• Stay at the leading edge of industry trends and agency requirements in the CGT analytical space as it pertains to development and transfer in the GMP environment.
• Proactively engage and lead troubleshooting activities for established methods by providing scientific support across the program life cycle.
• Independently create scientifically sound project development plans and relevant experiments using high-level project timelines and goals.
• Interpret data and analyze results to design follow-up experiments needed to complete assay development. Present results to management and at cross-group meetings.
• Write and review assay development and qualification protocols and reports, SOPS, technical documents, investigation summaries, and IND/BLA submission sections.
• Use statistical tools to develop quantitative measures in decision-making around assay development and performance.
• Use scientific literature to develop scientific arguments for white paper justifications, investigation conclusions, new technology, and process improvements.
• Produce and maintain accurate records.
• Represent group as SME on internal and external project teams. Serve as scientific lead for analytical methods at partner CRO/CDMOs.
• Train junior-level group members and act as a mentor within the laboratory.

This role might be for you if:

• You can comfortably work in a dynamic, fast-paced, closely collaborative environment, on multiple projects in parallel, independently or as a group.
• You're self-disciplined and proactive in your approach to meeting established project goals.
• You're detail-oriented, eager to learn and implement new ideas and techniques, and lead multiple projects in a team-based environment.
• You have excellent verbal, written, presentation, and interpersonal communication skills.
• You have an interest in leading project teams composed of junior staff.
• You're interested in developing into a mentor and leader within the group.

To be considered for the Analytical Scientist you must you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a PhD in Molecular Biology, Chemistry, Biochemistry, Cell Biology, Virology, Immunology, or related field. For various levels you must have the following:

• Analytical Scientist: 0- 2 years of relevant experience
• Sr. Analytical Scientist: 2 years of relevant experience

Prior experience in analytical method development, molecular biology, AAV, and CRISPR is highly preferred. Level is determined based on qualifications relevant to the role.