Principal Scientist

Biopharma Careers; United States; On-site; USD 108,000 - 176,000; Full time

Job summary

Regeneron is seeking a Principal Analytical Sciences Scientist to advance QC capabilities by developing, validating, transferring, and applying analytical methods for iSRNA/siRNA and peptide therapeutics. Located in Rensselaer, NY, this role leads technical strategy, collaborates across functions, and mentors junior staff.

Responsibilities include method lifecycle management, protocol design, and cross‑functional collaboration to ensure GMP release and characterization.

Qualifications

• PhD with 3+ years of experience in analytical development and QC method lifecycle.
• Experience developing and validating analytical methods for iSRNA/siRNA and peptide therapeutics.
• Proficient with chromatographic and mass spec techniques and data integrity practices.

Responsibilities

• Establish, develop, and optimize analytical methods for product and raw materials, with focus on iSRNA/siRNA and peptide modalities.
• Design and review protocols for assay qualification and validation (ICH Q2), ensuring stability-indicating methods for GMP release.
• Engage with collaborators and vendors to identify, assess, and implement new instrumentation and technology (LC-MS, CE, RP-HPLC, peptide mapping).
• Transfer control test procedures to QC and other departments, including drafting transfer plans, training materials, and acceptance criteria.
• Lead troubleshooting and provide analytical support for test methods, process and formulation issues (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, 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.

Skills

Analytical method development

Data integrity practices

Technical writing

Mentoring

Education

PhD in Chemistry/Biochemistry/Biology or related field

Tools

LC-MS/MS

CE

ion-pair RP-HPLC

peptide mapping

oligonucleotide characterization assays

Job description

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 protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$108,000.00 - $176,000.00