Sr. Manager, Chemical Development

Acadia Pharmaceuticals Inc. • San Diego, CA

7h • Hybrid

About The Position

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 role involves technical development, support, innovative solutions, and commercialization of drug substances using an external network of providers. The position is integral to the advancement of ACADIA’s growing portfolio of drug candidates, providing technical oversight, expertise, and guidance for externalized drug substance development related 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

Benefits

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree