Associate Director Chemical Development

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

 

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Associate Director, Chemical Development will be responsible for the chemical process development, implementation and management of robust, cost-effective, and safe processes for the manufacture of APIs from the research stage, through clinical development and marketing approval. This position will manage the technical development, support, provide innovative solutions, and commercialization of drug substances using an external network of providers. This position is integral to the advancement of Acadia’s growing portfolio of drug candidates and will provide technical oversight, expertise and guidance of externalized drug substance development related activities. The scope of the role encompasses a wide breadth of life-cycle, ranging from early stage development, late stage development, process validation, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role will be critical in ensuring optimized development, reduced risk profiles and ultimately accelerate the development cycle of assets.

Primary Responsibilities

• Provide strong scientific support to the overall chemical development team to ensure that the development plan provides for rapid and innovative process development and scale-up of drug substance incorporating quality, safety, compliance, cost-effectiveness, sustainability and reliability to meet development and commercial requirements
• Oversee contract development organizations to lead the development and optimization of drug substance processes to support the program from pre-clinical phase through marketing approval
• Perform risk assessments of manufacturing process scale-up and use Quality by Design (QbD) principles to define the design space and develop an overall control strategy
• Formulate drug substance development strategy to ensure product quality, facilitate regulatory approvals globally and achieve operational flexibility of supply chain
• Facilitate technology transfer, chemical outsourcing, external manufacturing to deliver a robust supply chain for all drug substances
• Foster an inclusive workplace, creating staff development opportunities, encouraging innovation, advocating a quality culture, maintaining safety and achieving high performance
• Engage in all facets of development from small scale synthesis to the development of the commercial synthetic route
• Develop and implement strategic and operational plans to deliver drug substance for multiple development projects to challenging timelines
• Initiate, evaluate and validate new drug substance CSPs (Contract Service Providers) to support commercialization scale-up
• Establish and maintain good working relationships with contract service providers, including negotiate and manage contracts and agreements
• Work with CSPs to diagnose and correct process issues
• Work with Quality function to determine the impact of process deviations and works toward resolutions
• Develop timelines, goals, and deliverables for drug substances and related manufacturing processes
• Optimize the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs
• Ensure the supply of drug substance is consistent with development plans by coordinating drug substance production in multiple CSP sites, managing contracts and invoices
• Ensure CSPs remain current and compliant with all cGMP related requirements, guidelines and procedures
• Track deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on