15 часов назад
Principal Analytical Sciences Scientist (Biotechnology)
108 000 - 176 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal Analytical Sciences Scientist (Biotechnology): Developing, validating, transferring, and maintaining analytical methods for siRNA oligonucleotides and peptide therapeutics with an accent on LCMS/MS, capillary electrophoresis, peptide mapping, GMP release, and method lifecycle management. Focus on troubleshooting complex analytical issues, leading OOS/OOT investigations, applying DOE and statistical trending, and aligning analytical strategy with QC, CMC, and regulatory milestones.
Location: Rensselaer, New York, United States; onsite, Monday–Friday, 8:00 a.m.–4:30 p.m.
Salary: $108,000–$176,000 annually
Company
features a role supporting Regeneron's analytical sciences, manufacturing, process sciences, and quality control activities.
What you will do
- Develop, optimize, troubleshoot, validate, transfer, and manage analytical methods for siRNA oligonucleotides and peptide therapeutics.
- Design and review assay qualification and validation protocols based on ICH Q2 principles, ensuring methods support GMP release and product characterization.
- Evaluate and implement analytical technologies including LCMS, capillary electrophoresis, ion-pair reverse-phase HPLC, hybridization-based assays, and peptide mapping.
- Transfer control test procedures to Quality Control and other departments by preparing transfer plans, training materials, and acceptance criteria.
- Lead troubleshooting, OOS/OOT investigations, deviation root-cause analysis, and customer complaint assessments.
- Represent Analytical Sciences in cross-functional teams, present technical findings, mentor junior staff, and maintain SOPs, protocols, and lifecycle documentation.
Requirements
- PhD in Chemistry, Biochemistry, Biology, or a related field.
- At least 3 years of relevant industry experience in analytical development and QC method lifecycle management.
- Demonstrated experience developing and validating methods for siRNA oligonucleotides and peptide therapeutics.
- Hands-on proficiency with LCMS/MS, capillary electrophoresis, ion-pair reverse-phase HPLC, peptide mapping, and oligonucleotide characterization assays.
- Experience with method transfer to QC, troubleshooting, OOS/OOT investigations, technical writing, data integrity, and cross-functional collaboration.
- Ability to work onsite in Rensselaer, New York, Monday through Friday, 8:00 a.m.–4:30 p.m.
Culture & Benefits
- Inclusive workplace and equal employment opportunity environment.
- Comprehensive rewards may include annual bonuses, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
- Reasonable accommodations are available during the recruitment process where required.
Hiring process
- Background checks may verify identity, right to work, and educational qualifications in accordance with applicable law.
- Final level and offer depend on qualifications, skills, experience, country of employment, and role requirements.
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