Staff Analytical Scientist

About the role

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.

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.

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.

Qualifications

PhD in Chemistry, Biochemistry, Biology, or related field, with 6+ years of relevant industry experience in analytical development and QC method lifecycle.

Level determined based on qualifications.