Principal Scientist, Bioanalytical Assay Development -Gene Therapy

Regeneron's Assay Development Group (ADG) is seeking a Principal Scientist to lead in the development and validation of DNA/RNA assays and immunoassays in support of viral vector gene therapy (GT) programs, showing strong decision making abilities in their area of expertise.

A Typical Day in the Role of Principal Scientist Might Look Like:

• Guide the designs and execution of genomic assays (PK, biodistribution, PD and ADA) by the team, based on protocols provided by literature, seminars and other scientists.
• Suggest troubleshooting experiments for assay-related problems follow-up experiments to further assay development and optimize assays.
• Writes/reviews assay validation protocols, reports and SOPs prior to submission to Quality Auditing (QA). Functions as Study Director for assay validation studies.
• Serve as SME for internal/external bioanalytical assay strategy and data interpretation; support CRO monitoring and outsourced activities
• Communicates with QA to schedule critical phase audits for validation studies and prepares audit responses.

This Role May Be For You If You:

• Optimally drive projects forward to meet aggressive timelines.
• Are comfortable composing regulatory submission documents and knowledge in the industry practice and regulatory mentorship on analytics development desired.

This role requires a Ph.D.and 3-8+ postdoctoral experience, or a MS degree with 10+ year experience or a BS degree 13+ of relevant experience laboratory experience. Experience in AAV-based gene therapies with a focus on development of novel bioanalytical assay platforms to support nonclinical and clinical development (i.e. biodistribution, shedding, PK, transgene encoded product, immunogenicity, on-target/off-target effects); knowledge of LNP and CRISPR/Cas9 technologies, as well as other viral vector GT platforms highly desirable. Hands-on knowledge in PCR (quantitative PCR and digital droplet PCR) and a proven understanding of additional methodologies to assess GT products such as deep sequencing approaches, high-resolution mass spectrometry and RNA hybridization assays a plus. Strong understanding of regulatory landscape for assays supporting bioanalytical assessments for viral-based gene delivery support Immunology/immunogenicity expertise for GT components (both highly developed and adaptive) a plus. Experience in a cGXP environment preferred.

#BioanalyticalSciences

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$121,200.00 - $197,800.00