Principal Scientist, Analytical Development, Oligo and Small Molecule

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Analytical Lead for CMC programs, primarily overseeing oligonucleotide analytical development tasks and providing support for small molecule initiatives.

• Oversee the development, qualification, validation, transfer, and GMP testing of analytical methods in collaboration with internal teams and external partners.

• Facilitate technical troubleshooting, data interpretation, method lifecycle management, and the review of analytical documentation such as validation reports, stability reports, specifications, and CoAs.

• Create and execute phase-appropriate analytical control strategies, specifications, and stability programs for both oligonucleotide and small molecule drug substances and products.

• Lead and manage CRO/CMO analytical partners to guarantee high-quality execution, effective communication, and ongoing operational enhancements.

• Work collaboratively across functions to enhance CMC operations, streamline processes, and develop scalable technical and business practices within the analytical domain.

• Provide strategic and technical insights to aid in regulatory submissions, readiness for commercialization, and continual product lifecycle management.

⛳️ Requirements

• An advanced degree (PhD preferred; Master’s with substantial industry experience considered) in Analytical Chemistry or a related field, accompanied by 5–7+ years of relevant industry experience.

• Significant industry experience in analytical development for oligonucleotide drug substances and/or drug products is essential.

• Experience in supporting small molecule drug substances and solid oral dosage forms is highly preferred.

• Comprehensive knowledge of analytical techniques applicable to oligonucleotides, including impurity characterization, stability evaluation, and GMP control strategies.

• Strong grasp of US and EU cGMP requirements and analytical best practices in drug substance and drug product development.

• Experience in supporting CMC development through various stages, including regulatory submissions, validation, and commercialization efforts.

• Proven experience in managing external CRO/CMO analytical networks and fostering productive technical collaborations.

• Solid understanding of quality systems, reference standards, stability programs, and compendial testing requirements.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision insurance plans.

• Life insurance paid by the company.

• AD&D, disability benefits, and optional plans to customize your coverage.

• 401(k) contributions matched dollar-for-dollar up to 6%.

• Long-term stock incentives and Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Flexible wellness benefits.

• Generous paid time off (PTO) and holiday pay.

• Company-wide shutdowns.