About the Role
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.
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.
Requirements
- Demonstrated experience developing and validating analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics.
- 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.
- Background checks may be conducted in accordance with the laws of the country where the position is based to verify information prior to commencement of employment such as identity, right to work and educational qualifications.
Skills
- Hands‑on proficiency with LC‑MS/MS, CE, ion‑pair RP‑HPLC, peptide mapping, and oligonucleotide characterization assays.
Location
- On-site
Work Type
- Full-time
Experience Level
- 6+ years of relevant industry experience in analytical development and QC method lifecycle
- Staff level
Education Level
- PhD in Chemistry, Biochemistry, Biology, or related field
Salary/Compensations
- $108,000.00 - $176,000.00
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
About the Company
- Regeneron believes we do our best work when we are together.
- 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.
Equal Opportunity
- Regeneron is 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.
