Principal Scientist

About the role

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.

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., LCMS, CE, ionpair RPHPLC, 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

• Demonstrated experience developing and validating analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics.
• Handson proficiency with LCMS/MS, CE, ionpair RPHPLC, 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.

Qualifications

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

Skills

• Experience with LCMS/MS, CE, ionpair RPHPLC, peptide mapping, and oligonucleotide characterization assays.
• Ability to design and execute experiments to assess and optimize technologies.
• Strong communication and mentoring skills.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Pay

$108,000.00 - $176,000.00 annually

Schedule

Monday-Friday 8am-4:30pm