Sr. Scientist, Analytical Development

In this role, you will serve as the Analytical Program Lead (APL) for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early post‑approval lifecycle activities. You will lead the definition and execution of program‑level analytical strategies to enable successful clinical introduction, licensure, and transition to commercial manufacturing. You will be responsible for driving analytical readiness for clinical and registrational stage programs, including specification setting, analytical control strategy development, and comparability strategy design and execution (e.g., process changes, site transfers, lifecycle evolution), as well as generation of robust data packages to support global submissions.

This role requires strong cross‑functional leadership and the ability to ensure alignment across development, manufacturing, quality, and regulatory teams. This is an individual contributor role focused on program delivery, scientific rigor, and regulatory excellence. The role also plays an integral part in authoring and reviewing regulatory sections and responding to RTQs across programs.

Serve as the Analytical Program Lead for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early lifecycle submissions.

Define and execute integrated analytical strategies, including specifications, analytical control strategy, comparability (process changes, site transfers, lifecycle), and assay lifecycle management.

Establish commercial specifications, control strategies, and comparability frameworks to enable initial licensure and post‑approval changes.

Ensure analytical readiness for clinical studies and commercial manufacturing, including method qualification/validation, transfer, and control strategy implementation.

Lead and author analytical sections of regulatory filings (e.g., IND and BLA/MAA) and responses to health authority questions/RTQs, ensuring clarity, consistency, and regulatory defensibility.

Partner cross‑functionally (QC, Regulatory CMC, MS&T, Manufacturing) to deliver robust, compliant, and inspection‑ready analytical data packages.

Identify and mitigate analytical risks, including defining acceptance criteria and justification strategies aligned with global regulatory expectations.

Mentor team members and contribute to consistent, high‑quality execution across programs. Additional duties may be assigned from time to time.

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years of relevant industry experience, or M.S./B.S. with 8+ years of experience in analytical development or quality control of biologics or vaccines.

• Experience in analytical development for biologics or nucleic acid‑based therapeutics, including experience with comparability strategy, study design, and regulatory justification.
• Understanding of analytical control strategy, specification setting, and method lifecycle management for initial licensure.
• Demonstrated experience authoring and reviewing analytical and CMC sections of BLAs/MAAs and responding to health authority queries.
• Knowledge of ICH guidelines, GMP, and global regulatory expectations for late‑phase development and commercial readiness.
• Proven ability to translate complex analytical data into clear, concise, and defensible regulatory narratives.
• Experience supporting technology transfer, method validation, and commercial site readiness.
• Cross‑functional collaboration skills with Regulatory, Quality, MS&T,…