Sr. Director, Chemical Development

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

Position Summary:

The Senior Director, Chemical Development will lead and advance endtoend drug substance development from early programs through commercial manufacturing. This role owns API process strategy, development, scaleup, and supply, while leading highperforming teams and overseeing external manufacturing partners. The Senior Director will define longterm drug substance strategy, support CMC development and commercial manufacturing, and author key regulatory submissions to ensure a reliable, compliant global supply.

Primary Responsibilities:

• 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.
• Initiates, evaluates and validates new drug substance CSPs to support commercialization scale up.
• Establish and maintain good working relationships with contract service providers.
• Negotiate and manage contracts and agreements.
• Work with CSPs to diagnose and correct process issues.
• Work with Quality and Regulatory Groups to determine the impact of process deviations and work towards 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, assess process scale-ability, increase process robustness, improve process efficiency, and reduce manufacturing costs.
• Ensure 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 for regulatory filings.
• Develop CMC plans for assigned projects, with special focus on API sourcing, drug product development and manufacture. Facilitate cross-functional planning of CMC activities across departments and disciplines to align dependencies, schedules, and funding.
• Collaborates 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 registration and process validation as needed to support manufacturing activities and resolve process issues, if any.
• Communicate drug substance related issues and information to committees, teams and interested groups within the company.
• Supervise, train and mentor personnel within the department and at the CSPs, as needed.
• Evaluate business development opportunities from a CMC perspective by providing technical support to due diligence activities.

Education/Experience/Skills:

• PhD in Organic Chemistry required.
• A minimum of 14 years' experience with progressively responsible positions within the pharmaceutical/biotechnology industry including a minimum of 8 years in a leadership role.
• A combination of relevant education and applicable job experience may be considered.

Must possess:

• Ability to lead in a strategic manner while being able to reduce concepts to practice.
• Strong understanding is required of the drug substance development process including regulatory quality inspections and audits.
• Contemporary awareness of scientific developments and opportunities in chemistry/chemical engineering.
• Is a highly credible technical functional expert with a strong understanding of organic synthetic chemistry concepts.
• Chemistry Manufacturing Controls (CMC) expertise is required to prepare documents for regulatory filing.
• Experience in establishing, managing and leading the CMC teams for pre-clinical through commercial development projects.
• Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs.
• Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced environment.
• Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.
• Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
• Domestic and Overseas Travel is required.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds weight. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business issues.

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