Associate Director, Analytical Development

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. The Associate Director, Analytical Development will be responsible for driving progress of both early and late-stage molecules by delivering phase-appropriate analytical methods, validation, and tech transfers.

Requirements

• Supporting analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances, and drug products
• Conducting analytical technical review of method validation/qualification protocols, data, and reports generated at CDMOs for drug substances and drug products
• Reviewing and approving analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
• Working on stability programs, monitoring/trending stability data, and establishing retest periods or shelf lives for drug substances or drug products
• Providing technical input and resolving analytical and quality control issues, deviations, OOS, and OOT investigations
• Supporting regulatory filings (IND, IMPD, NDA, MAA) submissions as needed
• Representing analytical Chemistry at internal and external scientific team meetings as needed
• Staying current with state-of-the-art approaches and applicable global regulations and industry standards

Benefits

• Competitive compensation and benefits package
• Open, flexible, and friendly work environment
• Equity, bonus, and benefits