Regeneron is seeking a Staff Analytical Sciences Scientist to support Manufacturing, Process Sciences (PS), and Quality Control (QC) by developing, optimizing, troubleshooting, validating, transferring, and applying analytical procedures across multiple modalities, including iSRNA/siRNA oligonucleotides and peptide therapeutics. You will advance QC capabilities by creating robust, phase‑appropriate and lifecycle‑managed analytical methods, integrating new assays and technologies, and serving as a technical leader who resolves complex issues and elevates analytical strategy for novel modalities.
A Typical Day in this Role May Include:
Establish, develop, and optimize analytical methods for product and raw materials, with a focus on iSRNA/siRNA and peptide modalities.
Design and review protocols for assay qualification and validation (e.g., ICH Q2 principles), ensuring methods are stability‑indicating and suitable for GMP release and characterization.
Engage with collaborators and vendors to identify, assess, and implement new instrumentation and technology (e.g., LC‑MS, CE, ion‑pair RP‑HPLC, hybridization‑based assays, peptide mapping).
Transfer control test procedures to QC and other relevant departments, including drafting transfer plans, training materials, and acceptance criteria.
Lead troubleshooting and provide analytical support for established test methods, process, and formulation issues (e.g., nuclease sensitivity in iSRNA, peptide oxidation/deamidation).
Conduct investigations (OOS/OOT), support deviation root‑cause analysis, and lead customer complaint assessments with data‑driven conclusions.
Present findings and scientific arguments in meetings and technical reports; communicate risk, impact, and mitigation strategies clearly.
Train and mentor junior team members; author and revise SOPs, protocols, and method lifecycle documents.
Manage the lifecycle of analytical testing methods (development, validation, transfer, change control, periodic review, and retirement).
Design and execute experiments independently to assess and optimize technologies; apply DOE and statistical trending where appropriate.
Produce and maintain accurate, compliant records consistent with data integrity and cGMP expectations.
Represent Analytical Sciences on interdepartmental teams and in program meetings; align analytical strategy with CMC and regulatory milestones.
This job may be for you if:
Demonstrated experience developing and validating analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics.
Hands‑on proficiency with LC‑MS/MS, CE, ion‑pair RP‑HPLC, peptide mapping, and oligonucleotide characterization assays.
Proven track record of method transfer to QC, troubleshooting, OOS/OOT investigations, and cross‑functional collaboration.
Strong technical writing, data integrity practices, and presentation skills; ability to mentor and lead.
To be considered for this position you must have a PhD in Chemistry, Biochemistry, Biology, or related field, with 6+ years of relevant industry experience in analytical development and QC method lifecycle.
Level determined based on qualifications.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)