Job Type
Full-time
Description
Sr. Director, Analytical Development
Location:Palo Alto, CA
Position Overview
This position will report directly to the Executive Director, CMC. This individual will assume a leadership role and actively engage in internal and external CMC activities for GondolaBio's small molecule programs, including analytical method development, method validation, method transfer, as well as review and approval of raw data, protocols, and reports. As a subject matter expert, the Sr. Director of Analytical Development will lead all aspects of Quality Control, including specification limit setting and justification for raw materials, intermediates, drug substances and drug product. The successful candidate will have extensive leadership experience supporting multiple small molecule programs through late-stage development, interacting with regulatory authorities, and successfully drafting and submitting IND/NDAs.
Responsibilities:
• Identifies, formulates strategies, prioritizes, and oversees analytical development activities to address complex problems.
• Collaborates and advises key stakeholders in senior leadership team, Research, Regulatory, Business Development & Operations, Quality Assurance, and Clinical Operations. Ensures timely communication of analytical issues and their impact on project timelines to peers and management.
• Lead internal and CDMO's analytical groups in developing new molecules from early development to NDA approval and launch.
• Lead development activities, establish specifications, and conduct stability studies.
• Design and implement analytical programs for RSM designation and dissolution method establishment.
• Design and execute detailed work plans with CDMOs, providing technical oversight.
• Author and approve regulatory documents and analytical methods for high-quality submissions and participate in regulatory interactions.
• Review SOPs, protocols, and investigation reports.
• Develop budgets, timelines, and staff projections for project goals.
• Manage and mentor a team of analytical scientists, providing scientific guidance, career development opportunities, and fostering a culture of innovation and collaboration.
Qualifications:
• Degree in analytical chemistry or related discipline (graduate degree preferred). PhD with 15+ years' experience.
• Strong experience in small molecule development and analytical method validation.
• Track record of leading programs through late-stage development and launch.
• Extensive expertise in analytical control strategies and method development.
• Experience in developing regulatory control strategy in the RSM, drug substance and drug product is highly desired.
• Knowledge of cGMP, cGLP, and regulatory requirements in multiple regions.
• Excellent organizational skills in a fast-paced, collaborative environment.
• Accurate project budgeting and timeline management.
• Independent and team-oriented with external CDMO management experience.
• Strong communication, mentoring, and leadership abilities.
• Contributing to project plans and effective presentation skills.
• Able to participate in early morning and/or late evening teleconferences with CDMOs and team members in other geographies, as required.
• Willingness to travel up to 20% of the time.
The base pay range for this position is $245,000 to $278,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.
