Principal Scientist

Regeneron is seeking a Principal 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.

When & Where:

Location:
Rensselaer, NY

Work Model:
Monday-Friday 8am-4:30pm

Discover Your Role:

• 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.
• 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.

This Role Requires:

A PhD in Chemistry, Biochemistry, Biology, or related field, with 3+ years of relevant industry experience in analytical development and QC method lifecycle.

• Level determined based on qualifications.

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic…