Associate Director, Analytical Development

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) in development for metastatic breast cancer, with blockbuster potential as monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow‑on product candidate, OP-3136, is a potent KAT6 inhibitor with best‑in‑class potential.

About the Role

Associate Director, Analytical Development reporting to the Senior Director of Analytical Chemistry will drive progress of both early and late‑stage molecules by delivering phase‑appropriate analytical methods, validation, and tech transfers. The role partners cross‑functionally with process development, formulations, CMC, and quality activities, and requires strong team‑playing and collaboration skills in a fast‑paced, growth‑stage biotech environment. This position can be based in San Francisco, CA or Boston, MA and requires 10‑15% travel.

Responsibilities

Primary responsibilities include:

• 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 analysis from CDMOs for batch release and stability testing of drug substances and drug products.
• Working on stability programs, monitoring and trending stability data, and establishing re‑test 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.
• Staying current with state‑of‑the‑art approaches and applicable global regulations and industry standards.

Candidate Profile

Knowledge

• MS or PhD in Chemistry or equivalent scientific discipline.
• Expertise in analytical development and quality control for both drug substances (emphasis) and drug products.
• Knowledge of cGMP, ICH, and FDA regulations/guidance.

Experience

• Minimum of 7+ years of relevant industry experience in small‑molecule drug substance and drug product analytical development and quality control, including late‑stage clinical development and preparation for product registration.
• Experience working in an environment that strives to maintain internal technical expertise while driving CDMO capabilities to meet milestones for multiple projects.
• Experience partnering with cross‑functional teams to provide analytical development leadership across programs and projects.
• Effective written, oral communication and interpersonal skills.

Attributes

• Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines.
• Self‑motivated and enthusiastic; fast learner who can identify core project challenges and expeditiously change course in a fast‑paced organization.
• Teamwork and collaboration; balances team and individual responsibilities, gives and welcomes feedback, puts team success above personal interests, and shares expertise.
• Aspires to the highest scientific and ethical standards.
• Keen to improve processes and overcome inefficiencies.

The base pay range for this position is expected to be $190,000‑$205,000 annually, which may vary depending on location, market, job‑related knowledge, skills and capabilities, and experience. The total compensation package also includes equity, bonus, and benefits.

Equal Opportunity

Olema provides equal opportunity to all employees and applicants for employment and believes that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

Benefits and Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long‑term careers. A summary of benefits is available for all applicants.

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