Key skills
Communication
About this role
Role Overview
- Serve as Analytical Lead across CMC programs, with primary responsibility for oligonucleotide analytical development activities and support for small molecule programs.
- Lead analytical method development, qualification, validation, transfer, and GMP testing activities across internal teams and external partners.
- Drive technical troubleshooting, data interpretation, method lifecycle management, and review of analytical documentation including validation reports, stability reports, specifications, and CoAs.
- Design and implement phase-appropriate analytical control strategies, specifications, and stability programs for oligonucleotide and small molecule drug substances and drug products.
- Direct and manage CRO/CMO analytical partners to ensure high-quality execution, strong communication, and continuous operational improvement.
- Collaborate cross-functionally to strengthen CMC operations, improve processes, and establish scalable technical and business practices across the analytical function.
- Contribute strategic and technical expertise to support regulatory filings, commercialization readiness, and ongoing product lifecycle management.
Requirements
- Advanced degree (PhD preferred; Master’s with significant industry experience considered) in Analytical Chemistry or related discipline with 5–7+ years of industry experience.
- Strong industry experience in analytical development for oligonucleotide drug substances and/or drug products required.
- Experience supporting small molecule drug substances and solid oral dosage forms strongly preferred.
- Deep knowledge of analytical techniques relevant to oligonucleotides, including impurity characterization, stability assessment, and GMP control strategies.
- Strong understanding of US and EU cGMP requirements and analytical best practices for drug substance and drug product development.
- Experience supporting CMC development across multiple stages of development, including regulatory submissions, validation, and commercialization activities.
- Experience managing external CRO/CMO analytical networks and building productive technical partnerships.
- Strong working knowledge of quality systems, reference standards, stability programs, and compendial testing requirements.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance.
- AD&D, disability benefits, and voluntary plans to personalize your coverage.
- 401(k) contributions matched dollar-for-dollar up to 6%.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO and paid holidays.
- Company-wide shutdowns.