Principal Scientist - Analytical Development for Drug Products

About the Role

We are looking for a Principal Scientist, Analytical Development – Drug Product to join our team at MapLight Therapeutics. This is a hybrid role, allowing you to work remotely while also collaborating with our team in Burlington, Massachusetts. As a Principal Scientist, you will lead analytical development efforts for small molecule oral drug products, ensuring robust characterization and regulatory compliance.

What You'll Do

• Lead the development and optimization of analytical methods for oral drug product in-process, release, and stability testing.
• Utilize a wide range of techniques such as HPLC, GC, LC-MS, and more to ensure method suitability for intended applications.
• Design and lead method validation activities to meet ICH, FDA, EMA, and other regulatory guidelines.
• Oversee method development and transfer activities at contract manufacturers and testing laboratories.
• Coordinate and oversee ICH stability programs for drug products at external vendors.
• Prepare, review, and approve technical documents such as SOPs and analytical methods.
• Author and review analytical sections of regulatory submissions and support regulatory interactions.
• Collaborate with formulation scientists and development teams to meet analytical needs across the product lifecycle.

Requirements

• PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related field with 5+ years of relevant industry experience; or M.S. with 7+ years; or B.S with 10+ years.
• Experience with analytical development in the pharmaceutical or biotechnology industry, including regulatory submissions.
• Proficiency in chromatography (HPLC, UPLC, GC), spectroscopy (MS, UV/Vis, FTIR), and other analytical techniques.
• Experience with method development, validation, transfer, and troubleshooting.
• Excellent written and verbal communication skills.

Nice to Have

• Experience with late phase development activities (registration/PPQ).
• Comprehensive understanding of ICH, FDA, EMA guidelines.

What We Offer

• Competitive salary range of $169,000—$200,000 USD.
• Annual bonus opportunity.
• Comprehensive medical, dental, and vision benefits.
• 401(K) plan with match and stock options.
• Flexible non-accrual paid time off and parental leave.