Analytical Scientist (Advanced Therapy Medicinal products)

East Greenbush, New York, United States of America
Jun 15, 2021
Required Education
Bachelors Degree
Position Type
Full time
The ATMP Analytical Scientist/Sr. Analytical Scientist is a driven subject matter specialist and leader in the laboratory and supports multiple areas of the organization. These areas include Manufacturing, Process Sciences (PS) and Quality Control (QC). We are looking for someone who can actively guide the development, optimization, troubleshooting, validation, transfer and application of analytical test procedures for advanced therapy medicinal products (ATMPs). This role crafts scientific arguments for white paper justifications and investigation conclusions as well as trains junior level group members within the laboratory.

As the ATMP Analytical Scientist/Sr. Analytical Scientist, a typical day might

include the following:
• Establishing and developing analytical methodology and viral safety assays to test the identity, strength, purity, potency, viral safety and stability of ATMPs
• Crafting and writing protocols for assay qualification/validation studies
• Developing test specifications and maintain the standard operating

• Transferring new or improved control test procedures to customer groups
• Supporting the Viral Safety Program as a specialist for viral clearance

validation review and viral safety which consists of the tripod PREVENT-DETECT-RESPOND
• Building the new analytical lab for ATMPs and transfer analytical methods from Regeneron Development site in Tarrytown or Contract Lab
• Performing viral safety project management to contribute to the response/filing of Regulatory information requests and review of Regulatory dossier sections
• Conducting viral safety assessment for ATMPs and QC lab practices (assay development, transfer and testing i.e. cell and molecular based assays, automation, rapid micro and Next Generation Sequencing (NGS) +bioinformatics)
• Writing group SOPs and providing drafts of proposed test methods to QC

This role might be for you:
• You demonstrate solid technical writing skills
• You are a strong communicator who can efficiently collaborate with cross-functional teams throughout the entire enterprise
• You continuously drive to improve processes for improved performance
• You work well within a collaborative environment

To be considered for this role, you must have a PhD in Chemistry, Biochemistry, or Bioengineering with 0-2 years of experience. For a Sr. Scientist role, a PhD and 3-5 years of experience are desired. We need someone who can optimally perform job duties with limited direction from leadership as well as conduct studies and experiments with a simple study goal.

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.