Associate Director Chemical Development

Please note that this position is based in Princeton, NJ. 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 regulatory filings
• Initiate and coordinate the preparation of CMC documentation
• Collaborate with Regulatory Affairs and other groups to support product filings
• Assist in contract site preparation activities for pre-approval inspections
• Support interdisciplinary working teams with recommendations, advice and action plans for drug substance-related issues
• Evaluate new process technology ensuring freedom to operate and expanding the IP for the company
• Provide onsite process coverage during process validation or as needed to resolve process issues
• Communicate drug substance related issues and information to committees, teams and interested groups within the company
• Support corporate development activities, serving as drug substance/chemistry expert, as part of cross-functional diligence teams to assess external assets/opportunities

Education and Experience

• PhD in synthetic organic chemistry or a related field. Targeting 8 years of experience in pharmaceutical research, development and manufacturing with 2 years’ experience in a leadership role preferably in the areas of process development, process characterization, process validation, drug substance manufacturing and/or product life cycle management. An equivalent combination of relevant education and experience may be considered.
• Leadership experience in managing diverse project activities with contract CDMO facilities at different global locations
• Experience with global pharmaceutical/chemical development and manufacturing operations for development-stage small molecules, including upstream/downstream process development. Well-versed in drug substance manufacturing control strategies
• Highly knowledgeable with FDA and ICH guidelines relating to registration, quality and compliance with small molecule drug substance
• Awareness of scientific developments and opportunities in chemistry/chemical engineering
• Strong understanding of organic synthetic chemistry concepts and cross-functional understanding related to API development and manufacturing from pre-IND through NDA
• Chemistry Manufacturing Controls (CMC) expertise to prepare documents for regulatory filing (e.g. IND to NDA)
• Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs
• Excellent communication, interpersonal and presentation skills
• Ability to effectively collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
• Skilled at negotiating with business partners/management and influencing senior level leaders regarding matters of significance to the organization
• Demonstrated problem-solving abilities and conflict resolution skills
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication both in a standard office environment and while working independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedule or business needs.

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