Director, Analytical Development

Olema Oncology is a biotech company developing better medicines for breast cancer and beyond. The Director, Analytical Development will lead analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products. The role requires a deep technical expertise, proven leadership, and ability to operate effectively in a fast-paced, growth-stage biotech environment.

Requirements

• PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control
• Minimum of 5 years direct leadership experience on managing internal and external teams
• Expertise of cGMP, ICH, and FDA regulations/guidance
• Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions
• Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones
• Demonstrated interpersonal skills, including strong oral and written communication abilities

Benefits

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