Senior Director, Chemical Development

This is a fully remote position, open to applicants in California.

📋 Description

• Identify, formulate, prioritize, and manage chemical development strategies and initiatives to tackle complex technical and supply challenges.

• Collaborate with senior leadership, Research, Regulatory, Quality Assurance, Drug Product, Supply Chain, and Clinical Operations, while promptly communicating chemical development risks and timeline impacts.

• Lead CDMO process chemistry teams in progressing small molecule drug substances from candidate selection to NDA approval and market launch.

• Direct route scouting, route selection, and process optimization efforts to enhance safety, robustness, yield, purity, scalability, cost, and availability of raw materials.

• Develop phase-appropriate impurity control strategies, including insights into impurity formation, fate, purge, and carryover, alongside addressing mutagenic impurity and nitrosamine risks.

• Oversee process scale-up, crystallization and isolation development, technology transfer, process characterization, validation, and GMP manufacturing activities.

• Design and implement detailed development and manufacturing work plans with CDMOs, providing active technical oversight and ensuring accountability for quality, timelines, budgets, and deliverables.

• Author and endorse regulatory documents, development reports, manufacturing documentation, and responses to health authority inquiries, while participating in regulatory interactions.

• Review and approve protocols, reports, batch records, deviations, investigations, change controls, and corrective and preventive actions.

• Develop budgets, timelines, and resource plans, managing and mentoring internal scientists, consultants, and external technical teams, while promoting a culture of urgency, ownership, and collaboration.

⛳️ Requirements

• Degree in organic chemistry, process chemistry, chemical engineering, or a related field.

• PhD with over 15 years of relevant experience in the pharmaceutical or biotechnology industry is preferred.

• Extensive background in small molecule synthetic route development, process chemistry, scale-up, technology transfer, and GMP drug substance manufacturing.

• Proven experience leading programs from early development stages to late-stage development, registration, and market launch.

• In-depth expertise in route optimization, reaction and workup design, crystallization, isolation, drying, and ensuring process robustness.

• Strong experience in developing impurity control strategies and comprehending impurity formation, fate, purge, and regulatory qualification.

• Familiarity with defining regulatory starting materials and managing raw materials, intermediates, mutagenic impurities, elemental impurities, residual solvents, and nitrosamine risks.

• Experience in process characterization, validation, commercial readiness, and preparing CMC regulatory submissions is highly sought after.

• Knowledge of cGMP, ICH guidance, quality-by-design principles, and regulatory requirements across multiple regions.

• Demonstrated success in a small biotechnology company, thriving in a fast-paced environment with shifting priorities and high individual accountability.

• Excellent organizational abilities with precise project budgeting, timeline management, and the capacity to oversee multiple programs concurrently.

• Independent and team-oriented, possessing strong domestic and international CDMO selection, governance, technical oversight, and performance management experience.

• Exceptional communication, mentoring, leadership, problem-solving, and presentation skills, with a dedicated and hands-on working approach.

• Availability to participate in early morning and/or late evening teleconferences with CDMOs and team members across different regions, and willingness to travel up to 20% of the time.

🏝️ Benefits

• Patient Days, where we have the privilege to hear directly from individuals living with the conditions we aim to impact throughout the year and understand how we can enhance our efforts.

• A culture rooted in our values: putting patients first, thinking independently, embracing radical transparency, valuing every minute, and allowing the science to guide us.

• A steadfast commitment to prioritizing patients at all times.

• A decentralized structure enabling our program teams to concentrate on advancing science and supporting patients.

• An affiliate framework designed to eliminate bureaucracy and empower decision-making at the grassroots level, closest to the science.

• A workplace where you take ownership of the vision – both for your program and your personal career trajectory.

• A collaborative, fast-paced, data-driven environment that inspires us to consistently perform at our best.

• Access to learning and development resources to help you reach your peak professional potential.

• A comprehensive and competitive compensation & benefits package (including Base, Performance Bonus, Equity, health, welfare & retirement programs).

• Flexible PTO.

• Rapid career advancement opportunities for high achievers.

• Potential to engage in multiple GondolaBio Pharma programs across various therapeutic areas over time.

• A strong commitment to Diversity, Equity & Inclusion.