Staff Analytical Scientist
Regeneron
9 hours ago
On-site
East Greenbush, NY
Operations
Staff Analytical Sciences Scientist
Responsibilities:
- Establish, develop, and optimize analytical methods for product and raw materials, focused on iSRNA/siRNA and peptide modalities.
- Design and review assay qualification/validation protocols (e.g., ICH Q2 principles) to ensure stability-indicating methods suitable for GMP release and characterization.
- Evaluate and implement new instrumentation/technologies with collaborators and vendors (e.g., LC-MS, CE, ion-pair RP-HPLC, hybridization-based assays, peptide mapping).
- Transfer control test procedures to QC and other departments, including transfer plans, training materials, and acceptance criteria.
- Lead troubleshooting and provide analytical support for test methods and process/formulation issues (e.g., nuclease sensitivity, 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; clearly communicate risk, impact, and mitigation.
- Train/mentor junior team members; author/revise SOPs, protocols, and method lifecycle documents.
- Manage analytical method lifecycle (development, validation, transfer, change control, periodic review, retirement).
- Design/execute independent experiments; apply DOE and statistical trending when appropriate.
- Maintain accurate, compliant records aligned with data integrity and cGMP.
- Represent Analytical Sciences on cross-functional teams; align analytical strategy with CMC and regulatory milestones.
Qualifications:
- PhD in Chemistry, Biochemistry, Biology, or related field.
- 6+ years industry experience in analytical development and QC method lifecycle.
Skills/Experience:
- Experience developing/validating analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics.
- Hands-on proficiency: LC-MS/MS, CE, ion-pair RP-HPLC, peptide mapping, and oligonucleotide characterization assays.
- Track record of method transfer to QC, troubleshooting, OOS/OOT investigations, and cross-functional collaboration.
- Strong technical writing, data integrity practices, presentation skills; ability to mentor/lead.
Application:
- Apply now.
Responsibilities:
- Establish, develop, and optimize analytical methods for product and raw materials, focused on iSRNA/siRNA and peptide modalities.
- Design and review assay qualification/validation protocols (e.g., ICH Q2 principles) to ensure stability-indicating methods suitable for GMP release and characterization.
- Evaluate and implement new instrumentation/technologies with collaborators and vendors (e.g., LC-MS, CE, ion-pair RP-HPLC, hybridization-based assays, peptide mapping).
- Transfer control test procedures to QC and other departments, including transfer plans, training materials, and acceptance criteria.
- Lead troubleshooting and provide analytical support for test methods and process/formulation issues (e.g., nuclease sensitivity, 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; clearly communicate risk, impact, and mitigation.
- Train/mentor junior team members; author/revise SOPs, protocols, and method lifecycle documents.
- Manage analytical method lifecycle (development, validation, transfer, change control, periodic review, retirement).
- Design/execute independent experiments; apply DOE and statistical trending when appropriate.
- Maintain accurate, compliant records aligned with data integrity and cGMP.
- Represent Analytical Sciences on cross-functional teams; align analytical strategy with CMC and regulatory milestones.
Qualifications:
- PhD in Chemistry, Biochemistry, Biology, or related field.
- 6+ years industry experience in analytical development and QC method lifecycle.
Skills/Experience:
- Experience developing/validating analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics.
- Hands-on proficiency: LC-MS/MS, CE, ion-pair RP-HPLC, peptide mapping, and oligonucleotide characterization assays.
- Track record of method transfer to QC, troubleshooting, OOS/OOT investigations, and cross-functional collaboration.
- Strong technical writing, data integrity practices, presentation skills; ability to mentor/lead.
Application:
- Apply now.