Sr Scientist, Analytical Development – Novel DPP1

About the role

We’re looking for a Senior Scientist, Analytical Development on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Analytical Development, you’ll lead analytical development efforts for small-molecule drug substances and drug products. This role will support early- to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline toward clinical and commercial success.

Responsibilities

In this role, you’ll have the opportunity to lead the development and optimization of analytical methods for starting materials, intermediates, drug substances, and drug products.

• Utilize a wide range of analytical techniques, including HPLC, GC, LC-MS, NMR, UV, and FTIR, to ensure method suitability for intended applications.
• Design and lead method validation activities to ensure compliance with ICH, FDA, EMA, and other applicable regulatory guidelines.
• Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer.
• Prepare, review, and approve technical documents, including standard operating procedures (SOPs), analytical methods, protocols, reports, and product specifications.
• Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert.
• Collaborate with process chemistry, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.
• Lead or contribute to cross-functional project teams, manage analytical development timelines, and communicate progress to stakeholders.
• Serve as the Analytical Lead for CMC programs, overseeing analytical deliverables, including method development, validation, and GMP testing for both internal teams and external partners.
• Manage and oversee external service providers supporting analytical development activities, ensuring timely deliverables and continuous process improvements.
• Provide technical troubleshooting, data interpretation, and review of analytical data, including method validation documents, Certificates of Analysis (CoAs), and stability reports.
• Lead the design and development of phase-appropriate quality control strategies, specifications, and stability programs for