Director, Head of Chemical Development
You will drive the development and implementation of robust synthetic processes to support the manufacturing of small molecule drug substances for clinical studies. You will coordinate and manage multiple CMOs with the goal of routinely delivering drug substances for toxicological and clinical studies. Working closely with the R&D organization (Research, Quality, Clinical Development, and Regulatory), you will develop drug substance manufacturing strategies to meet Maze’s objectives of translating genetic insights into medicines.
This position reports to the VP of Technical Operations.
Your Impact:
- Leading phase appropriate design, implementation of synthetic processes for regulatory starting materials, intermediates, and APIs to deliver a robust chemical synthesis process into registration batch campaign.
- Establishing the framework for the control strategy for the drug substance.
- Reviewing proposals from Contract Manufacturing Organizations (CMOs). Performing appropriate due diligence to ensure CMOs can support the requirements of individual chemical development programs effectively.
- Implementing QbD and DoE principles at appropriate development stages
- Supporting pre-validation (such as PAR studies and purging studies) and validation activities for drug substance
- Authoring and reviewing relevant CMC sections for regulatory filings.
- Being responsible for the functional budget projection and operate within the budget
Leadership Competencies
- Communication and Influence
- Builds communication channels across Maze for sharing information
- Influences Senior Management decisions through persuasive arguments
- Respectfully addresses differing opinions leading to support of decision
Teamwork and Collaboration
- Champions partnerships and connections across Maze
- Proactively addresses issues that could result in breakdown of team relationships
- Spotlights team and individual contributions in public forums
Execution and Results
- Addresses gaps and leverages strengths to get best results
- Maintains a steadying presence and clarifies priorities during change
- Anticipates and removes barriers that put functional/corporate goals at risk
Develop Others and Self
- Removes barriers to staff development and empowers them to make their own decisions
- Stays current on industry trends and keeps direct-reports prepared and responsive
Skills and Qualifications:
- Ph.D. in synthetic organic chemistry or equivalent experience with a minimum 12 years of experience in the small molecule pharmaceutical industry.
- Laboratory training and hands-on experience in a kilo laboratory setting required.
- Comprehensive understanding of the process techniques for polymorph screening and particle size optimization
- Ability to interact and effectively share synthetic route design and process development knowledge with cross functional teams.
- Comprehensive understanding of cGMPs, ISO, and ICH guidelines, and industry best practices.
- Understanding of Design of Experiments (DOE) and Quality by Design (QbD) principals.
- Effective communication within a cross-functional team setting and through line management
- Self-directed and proactive, with the ability to thrive in fast-paced, dynamic environment with high performance colleagues to deliver high impactful results
- Collaborative spirit establishing trust, seeking knowledge, and utilizing your expertise to generate best outcomes
- Ability to travel as necessary (up to 20%) to deliver CMC goals through external partners.
About Maze Therapeutics
Maze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients, with a focus on genetically informed therapies for common diseases such as chronic kidney disease. Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines. Maze has developed the Maze Compass Platform TM, a proprietary, purpose-built platform to understand and integrate the critical step of variant functionalization into each stage of drug development. Utilizing the Maze Compass PlatformTM, Maze is building a broad portfolio of wholly owned and partnered programs. Maze is based in South San Francisco.