Regeneron's Assay Development Group (ADG), located in Tarrytown, NY, is seeking a Sr Scientist to join the team. In this exciting role, you will critically evaluate ongoing processes and suggest improvements, especially those that ensure compliance with current GxP guidance documentation.
A Typical Day in the Role Might Look Like:
- Independently craft, perform, complete and troubleshoot immune-assays (e.g., ELISA) and DNA/RNA assays (qPCR/ddPCR) based on protocols provided by literature, supervisor and other scientists
- Develop and optimize sophisticated genomic assays and immunoassays (i.e. PK, biodistribution, PD and ADA)
- Routinely perform multiple assays within the same day and works on multiple projects simultaneously
- Identify and independently evaluate new technologies for the development of assays using new formats or techniques.
- Write assay validation protocols with few or no subsequent edits for review by supervisor and/or Study Director
- Takes the lead/supervisory role in planning of validation experiments and securing resources and reagents for validation
- May independently train on validated bioanalytical methods and perform sample analysis, if needed
- Maintain GLP compliance for all laboratory work and documentation related to assay validations in accordance with FDA regulations and company SOPs
- Ensure GLP compliance is maintained in the laboratory
This Role May Be for You If:
- You have strong initiative and drive to complete ambitious tasks and learn new technologies.
- You are capable of multi-tasking, working both independently and within a team environment.
This role requires a Doctorate Degree (Ph.D.) in biology or a related field and a minimum of 2-3+ years of relevant post-doctoral experience. Experience in AAV-based gene therapies with a focus on development of novel bioanalytical assay platforms to support nonclinical and clinical and knowledge of LNP and CRISPR/Cas9 technologies, as well as other viral vector GT platforms is 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 GXP environment preferred.
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)
$103,600.00 - $169,000.00