Analytical Development Principal Scientist (Small Molecules)

Location: Boston, MA; five days per week on-site

Salary: $140,800–$211,200 per year, plus annual bonus and equity awards

Company

Global biotechnology company 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, specifications, in-process controls, analytical methods, retest periods, and storage and shipping conditions for drug substances, intermediates, and starting materials.
• Act as a subject matter expert for analytical development with contract manufacturing and testing laboratories.
• Assess chemical and solid-state development factors that affect quality, method performance, and analytical activities.
• Prepare and review source documents for regulatory submissions and present analytical issues and solutions to cross-functional teams.

Requirements

• Ph.D. with 4+ years of relevant analytical development experience focused on novel small molecule drug substances; alternatively, an M.S. with 7+ years or a B.S. with 10+ years of high-level experience.
• Experience or working knowledge of control strategy development, spike and purge studies, and drug substance QbD process development.
• Strong understanding of cGMP, ICH, FDA, and USP guidelines, including impurity control and ICH M7.
• Experience with modern analytical techniques for small molecule pharmaceuticals, particularly chromatography.
• Knowledge of synthetic organic chemistry, drug substance development, process chemistry, and pharmaceutical manufacturing.
• Strong communication skills and the ability to work independently and in a matrix environment while managing multiple projects.

Culture & Benefits

• Continuous learning focused on advances in AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits with paid time off and seasonal company shutdowns.
• Educational assistance, student loan repayment, commuting subsidy, charitable donation matching, and 401(k).
• Equal employment opportunity and reasonable accommodations for qualified applicants.