Senior Director Chemical Development - ACADIA Pharmaceuticals

The Senior Director in the Chemical Development organization at Acadia is responsible for the chemical process development, implementation, and management of robust, efficient, and safe processes for the APIs from the research stage, through clinical development and marketing approval. This person will oversee technical development, support, and innovative solutions for the production 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 mentorship of externalized drug substance development-related activities.

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 driving the development and optimization of drug substance processes to support the program from the 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 overall control strategy.
• Formulate drug substance development strategy to ensure product quality, facilitate regulatory approvals and achieve operational flexibility of supply chain.
• Facilitate technology transfer, chemical outsourcing, external manufacturing to deliver a robust supply chain for all drug substances.
• Engage in all facets of development and create small-scale synthesis to the development of the commercial synthetic route.
• Develop and implement strategic and operational plans to deliver drug substances for multiple development projects with crucial timelines.
• Initiate, evaluate and validate new drug substance CSPs (Contract Service Providers) to support commercialization scale-ups.
• Negotiate and lead supplier contracts and agreements.
• Work with CSPs to diagnose and troubleshoot process issues.
• Work with Quality Group to resolve 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, increase process robustness, improve process efficiency, and reduce production costs.
• Ensure the supply of drug substance is consistent with development plans by coordinating drug substance production in multiple CSP sites, leading contracts and invoices.
• Track deviations and process changes from the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
• Coordinate the preparation of CMC documentation to support manufacturing and regulatory 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 activities and 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.
• Supervise, train, and mentor personnel as opportunities become available.
• Support corporate development activities, serving as drug substance/chemistry authority, as part of cross-functional diligence teams to assess external assets or in-licensing opportunities.

Education/Experience/Skills

• A PhD degree in synthetic organic chemistry with around demonstrated ability in pharmaceutical research, development and manufacturing in the biotechnology or pharmaceutical industry.
• BS/MS degree with equivalent experience is required and could be considered with shown experience.
• Desired 10 years’ experience in a leadership role in the areas of process development, process characterization, process validation, and product life cycle management

Must Possess:

• Leadership experience in running 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 experience in drug substance manufacturing control strategies, FDA and ICH guidelines relating to registration, quality, and compliance concerning small molecule drug substances.
• Cross-functional understanding related to API development from pre-IND through NDA stages.
• Chemistry Manufacturing Controls (CMC) expertise to prepare technical documents for regulatory filings (e.g. IND to NDA).
• Extensive knowledge of current Good Manufacturing Practices (cGMPs) and experience in chemical development for new drugs.
• Excellent interpersonal and leadership skills, excellent communication, interpersonal and presentation skills.
• Strong discernment including business contracting expertise.
• Skills at negotiating with business partners/management and influencing senior-level leaders regarding matters of significance to the organization.
• Proficiency at creating and delivering a clear vision among team members optimally aligning resources and activities to achieve functional area and/or company goals.
• Employee must be fully vaccinated against Covid-19 in accordance with our policy.

Scope

This position establishes strategic plans for designated function(s) and participates with senior management to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the functional area and related interpersonal objectives. Erroneous decisions will have a serious impact on the overall success of the organization and the company.

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. Domestic and Overseas. Employee must be fully vaccinated against Covid-19 in accordance with our policy and in order to meet any independent vaccination requirements that our clients and client facilities may have.

#LI-Hybrid #LI-MH1