Associate Director, Analytical Development

About the Role

Associate Director, Analytical Development reporting to the Senior Director of Analytical Chemistry. Responsible for driving progress of early and late‑stage molecules by delivering phase‑appropriate analytical methods, validation and tech transfers. The role may be based in San Francisco, CA or Boston, MA and requires 10-15% travel.

Key Responsibilities

• 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

Ideal 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 product
• 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 ensure internal technical expertise in‑house while driving CDMO capabilities to meet milestones for multiple projects
• Experience in partnering with cross functional teams providing 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 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
• Aspires to the highest of scientific and ethical standards
• Keen to improve processes and overcome inefficiencies

Base pay range for this position is $190,000–$205,000 annually; the total compensation package also includes equity, bonus, and benefits.

Benefits

Competitive compensation and benefits package, open, flexible, and friendly work environment to empower employees and provide a platform to develop long‑term careers.

Equal Employment Opportunity

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. A summary of benefits is available for all applicants.

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