Senior Director, Analytical Development at GONDOLABIO SERVICECO INC

Palo Alto, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

278000.0

Posted On

13 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Development, Method Validation, Method Transfer, Quality Control, Specification Limit Setting, Small Molecule Programs, Regulatory Submissions, IND/NDA Drafting, Stakeholder Collaboration, CDMO Management, Stability Studies, cGMP, cGLP, Budget Development, Team Mentoring, Scientific Guidance

Industry

Biotechnology Research

Description

Description Sr. Director, Analytical Development Location:Palo Alto, CA About GondolaBio GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. 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. What We Offer Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak An unyielding commitment to always putting patients first. A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science A place where you own the vision – both for your program and your own career path A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game Access to learning and development resources to help you get in the best professional shape of your life Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) Flexible PTO Rapid career advancement for strong performers Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time Partnerships with leading institutions Commitment to Diversity, Equity & Inclusion 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.

Responsibilities

This leadership role involves overseeing all analytical development activities for small molecule programs, including method development, validation, and transfer, while acting as a subject matter expert for Quality Control and specification setting. The director will lead internal and CDMO analytical groups from early development through NDA approval and launch, authoring regulatory documents and managing budgets.