Staff Analytical Scientist
Regeneron
10 days ago
On-site
Rensselaer, NY
Operations
Responsibilities:
- Establish, develop, and optimize analytical methods for product and raw materials (focus on iSRNA/siRNA and peptide modalities).
- Design/review assay qualification and validation protocols (e.g., ICH Q2) ensuring stability-indicating methods for GMP release and characterization.
- Evaluate and implement new instrumentation/technologies (LC-MS, CE, ion-pair RP-HPLC, hybridization-based assays, peptide mapping) with collaborators/vendors.
- Transfer control test procedures to QC and other departments (transfer plans, training materials, acceptance criteria).
- Troubleshoot and provide analytical support for test methods, process, and formulation issues (e.g., iSRNA nuclease sensitivity; peptide oxidation/deamidation).
- Lead OOS/OOT investigations, deviation root-cause support, and customer complaint assessments with data-driven conclusions.
- Present findings and scientific arguments; communicate risk/impact/mitigation clearly.
- Train/mentor junior staff; author/revise SOPs, protocols, and method lifecycle documents.
- Manage analytical method lifecycle (development, validation, transfer, change control, periodic review, retirement).
- Independently design/execute experiments; apply DOE and statistical trending where appropriate.
- Maintain accurate, compliant records consistent with data integrity and cGMP.
- Represent Analytical Sciences on cross-functional teams; align analytical strategy with CMC and regulatory milestones.
Qualifications/Requirements:
- PhD in Chemistry, Biochemistry, Biology, or related field.
- 6+ years of relevant industry experience in analytical development and QC method lifecycle.
- Experience developing/validating analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics.
Skills (Required/Preferred):
- Hands-on proficiency with 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; cross-functional collaboration.
- Strong technical writing, data integrity practices, presentation skills; ability to mentor/lead.
Application instructions:
- Apply now to be considered for the position.
- Establish, develop, and optimize analytical methods for product and raw materials (focus on iSRNA/siRNA and peptide modalities).
- Design/review assay qualification and validation protocols (e.g., ICH Q2) ensuring stability-indicating methods for GMP release and characterization.
- Evaluate and implement new instrumentation/technologies (LC-MS, CE, ion-pair RP-HPLC, hybridization-based assays, peptide mapping) with collaborators/vendors.
- Transfer control test procedures to QC and other departments (transfer plans, training materials, acceptance criteria).
- Troubleshoot and provide analytical support for test methods, process, and formulation issues (e.g., iSRNA nuclease sensitivity; peptide oxidation/deamidation).
- Lead OOS/OOT investigations, deviation root-cause support, and customer complaint assessments with data-driven conclusions.
- Present findings and scientific arguments; communicate risk/impact/mitigation clearly.
- Train/mentor junior staff; author/revise SOPs, protocols, and method lifecycle documents.
- Manage analytical method lifecycle (development, validation, transfer, change control, periodic review, retirement).
- Independently design/execute experiments; apply DOE and statistical trending where appropriate.
- Maintain accurate, compliant records consistent with data integrity and cGMP.
- Represent Analytical Sciences on cross-functional teams; align analytical strategy with CMC and regulatory milestones.
Qualifications/Requirements:
- PhD in Chemistry, Biochemistry, Biology, or related field.
- 6+ years of relevant industry experience in analytical development and QC method lifecycle.
- Experience developing/validating analytical methods for iSRNA/siRNA oligonucleotides and peptide therapeutics.
Skills (Required/Preferred):
- Hands-on proficiency with 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; cross-functional collaboration.
- Strong technical writing, data integrity practices, presentation skills; ability to mentor/lead.
Application instructions:
- Apply now to be considered for the position.