Analytical Chemistry Research Advisor (Peptides & Oligonucleotides)

Quick Facts

• Role: Analytical lead for early-phase synthetic peptide and oligonucleotide (TIDES) programs

Description

Serve as the analytical lead for early-phase TIDES molecules, owning phase-appropriate control strategies for both drug substance and drug product from preclinical enabling studies through first-in-human clinical supply. Provide technical direction to CMO/CRO partners, oversee GLP/GMP analytical campaign elements, and translate external work into control strategies and IND documentation that support Phase 1 entry. Author and review IND and CTA CMC analytical sections, including specifications and stability programs.

Responsibilities

• Own the analytical package for early-phase TIDES molecules and define the phase-appropriate control strategy
• Define analytical deliverables, approve method development and qualification protocols/reports, oversee method transfer and verification, assess external data packages, and drive resolution of OOS/OOT results and analytical investigations
• Oversee GLP and GMP analytical elements: readiness assessment, release and in-process testing, reference standard qualification, batch data review, and support disposition with Quality
• Author and review analytical CMC sections of INDs and CTAs (analytical procedures, validation summaries, specification justification, batch analyses, impurity and stability sections) and support responses to health authority questions
• Establish and justify phase-appropriate specifications and stability programs (related substances/process-related impurities, residual solvents and reagents per ICH Q3C and M7, elemental impurities, water and counterion, potency, and microbiological quality/endotoxin)
• Collaborate across chemists, formulation scientists, engineers, Quality, and Regulatory CMC to integrate analytical strategy with program plans; manage multiple concurrent molecules

Requirements

• Ph.D. in analytical chemistry or bioanalytical chemistry (or closely related) with 2+ years relevant industry experience; or M.S. with 5+ years; or B.S. with 7+ years in pharmaceutical/biotechnology analytical development
• Analytical method development/qualification/validation and transfer experience for peptides, oligonucleotides, or small molecules
• Deep working knowledge of chromatographic separations (reversed-phase, size exclusion, ion exchange) and mass spectrometry; general understanding of UV, GC, KF, ICP, NMR and other synthetic-molecule techniques
• Experience applying method performance attributes (specificity, linearity, precision, accuracy, LOD/LOQ) to define fit-for-purpose early-phase expectations
• Experience in a GMP environment and familiarity with ICH and compendial requirements (USP/Ph. Eur.)
• Strong written and verbal communication skills for cross-functional and external audiences

Benefits

• Comprehensive benefits program including 401(k) and pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance and death benefits, time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs and activities)