Sr Analytical Scientist

Regeneron Pharmaceuticals • Rensselaer, NY

1d • Onsite

About The Position

Regeneron is seeking a Sr. 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.

Requirements

• BS/BA in Chemistry, Biochemistry, Biology, or related field, with 5+ years of relevant industry experience in analytical development and QC method lifecycle.
• 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.

Nice To Haves

• PhD degree is preferred.

Responsibilities

• 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.

Benefits

• 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!
• award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level