Director, Analytical Chemistry

The Role:

We are seeking an experienced, driven colleague to lead our analytical development and quality control effort. This role will report to the Senior Director, Analytical Chemistry and will be responsible for driving progress of both early- and late-stage molecules by delivering phase-appropriate analytical methods and validation.

This is a fantastic opportunity for a hands-on Director, Analytical Chemistry to join a company with an industry leading Board of Directors and Management team. This analytical chemistry leader will roll up their sleeves to help build and grow an innovative women’s oncology company with significant potential to transform breast cancer treatments. 

This position is available in our San Francisco office.

What You Will Do:

• Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
• Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
• Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
• Manage stability programs, monitor trending stability data and establish retest periods or shelf lives for drug substances or drug products
• Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
• Author appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions as needed
• Represent Analytical Chemistry at internal and external scientific team meetings as needed
• Remain current with state-of-the art approaches and applicable global regulations and industry standards

What You Will Bring:

• PhD with 10 years or MS with 15 years of relevant industry experience and exposure to small molecule drug substance analytical development and quality control, including late-stage clinical development and preparation for product registration
• Minimum 5 years direct leadership experience on managing internal and external teams
• Expertise in analytical development and quality control for both drug substance and drug product
• Knowledge of cGMP, ICH, and FDA regulations/guidance
• Experience authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
• Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects

Personal Characteristics:

Given the “small biotech” nature of the Company, the overall cultural add of the successful candidate is an important criterion for their success at Olema. Desired characteristics include a high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this job.

Specific personal characteristics include:

• Excellent verbal and written communication and skills coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadline
• A commitment to excellence
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required
• Be a “difference maker” in terms of one’s professionalism and contributions
• Have impeccable professional ethics, integrity and judgment
• Be collegial, hard-working, confident, a self-starter and have a passion for results

The base pay range for this position is expected to be $218,000 - $230,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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