Sr. Manager, Chemical Development

Acadia Pharmaceuticals • San Diego, NJ

2d • Hybrid

About The Position

Acadia Pharmaceuticals is dedicated to transforming scientific discoveries into significant innovations for underserved neurological and rare disease communities globally. The company's commercial portfolio includes FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome, and it is actively developing new therapeutic advancements with a robust pipeline, including mid- to late-stage programs for Alzheimer’s disease psychosis and Lewy body dementia psychosis, as well as earlier-stage programs addressing other patient needs. This position can be based in Princeton, NJ, or San Diego, CA, and operates under Acadia's hybrid model, requiring an average of 3 days per week in the office. The role is responsible for the chemical process development, implementation, and management of robust, cost-effective, and safe processes for manufacturing Active Pharmaceutical Ingredients (APIs) from the research stage through clinical development and marketing approval. This includes technical development, support, innovative solutions, and commercialization of drug substances through an external network of providers. The position is crucial for advancing ACADIA’s growing portfolio of drug candidates, providing technical oversight, expertise, and guidance for externalized drug substance development activities.

Requirements

• Ph.D. degree in Synthetic Organic Chemistry or other related scientific discipline
• A minimum of 8 years of relevant progressive experience in API development and manufacturing in the pharmaceutical/biotechnology industry with a minimum of 5 years in a scientific role
• An equivalent combination of relevant education and applicable job 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 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

Responsibilities

• Lead scientific strategy for drug substance development, ensuring scalable, efficient, and compliant processes that meet clinical and commercial needs
• Oversee contract service providers (CSPs) to develop, optimize, and scale manufacturing processes from preclinical through commercialization
• Apply risk assessments and Quality by Design (QbD) principles to define design space and establish robust control strategies
• Develop end-to-end drug substance strategies supporting product quality, global regulatory approvals, and supply chain flexibility
• Manage technology transfer, outsourcing, and external manufacturing to build a reliable and scalable supply chain
• Establish, evaluate, and manage CSP partnerships, including contract negotiation, performance oversight, and issue resolution
• Ensure cGMP compliance, oversee deviations and change management, and partner with Quality and Regulatory to assess impact on filings
• Lead planning and execution of timelines, deliverables, and CMC documentation to support regulatory submissions and inspections
• Provide cross-functional leadership and technical expertise, supporting internal teams, governance forums, and external diligence activities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees