Analytical Development Principal Scientist

TL;DR

Analytical Development Principal Scientist (Small Molecule Pharmaceuticals): Developing analytical control strategies and methods for novel drug substances across clinical and commercial-enabling phases with an accent on process development, impurity control, and regulatory alignment. Focus on designing QbD-based analytical programs, solving complex drug substance quality challenges, and guiding external manufacturing and testing partners.

Location: Boston, MA; five days per week on-site with ad hoc flexibility.

Salary: $140,800–$211,200 base salary, plus potential annual bonus and equity awards.

Company

Global biotechnology organization focused on scientific innovation and the development of medicines.

What you will do

• Design and oversee analytical activities for drug substance process development across clinical and commercial-enabling phases using Quality by Design principles.
• Develop control strategies, analytical methods, in-process controls, specifications, retest periods, and storage and shipping conditions for drug substances, intermediates, and starting materials.
• Act as a subject matter expert for analytical development with external drug substance manufacturing and testing partners.
• Assess chemical and solid-state development factors affecting quality, method performance, and analytical activities.
• Prepare and review analytical source documents for regulatory submissions.
• Present analytical issues and solutions to cross-functional project teams while managing multiple timelines.

Requirements

• Ph.D. with 4+ years of relevant analytical development experience; alternatively, an M.S. with 7+ years or a B.S. with 10+ years of high-level experience.
• Experience developing novel small molecule drug substances and understanding their process development, process chemistry, and pharmaceutical manufacturing.
• Working knowledge of control strategy development, spike and purge studies, and drug substance QbD process development.
• Understanding of cGMP, ICH, FDA, and USP guidelines, including impurity control and ICH M7.
• Expertise in modern analytical techniques for small molecule pharmaceuticals, particularly chromatography.
• Strong communication, collaboration, prioritization, and independent working skills.

Culture & Benefits

• Full-time, on-site work with ad hoc flexibility.
• Medical, dental, and vision benefits with paid time off and seasonal company shutdowns.
• Educational assistance, including student loan repayment programs.
• Commuting subsidy, charitable donation matching, and 401(k) benefits.
• Annual bonus and equity award eligibility.