Associate Director Analytical Development Drug Product

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

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.

Responsible for oversight of the outsourced analytical development activities associated with the development, validation, technology transfer, and line extension of drug product. Support pre-formulation and drug product characterization activities. Manages multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical development results related to drug product development in reports and certificates of analysis.

Primary Responsibilities

• Develops and validates analytical methods for small molecules in various dosage forms:
• Participates with others to plan analytical development and testing requirements.
• Collaborates with testing labs to develop analytical methods.
• Drafts and/or reviews method validation protocols and reports.
• Drafts and/or approves analytical methods.
• Provides information for chemistry, manufacturing and control (CMC) section of regulatory documentation.
• Provides oversight of testing at contract service providers (CSPs):
• Reviews testing sections of process development protocols and reports.
• Define testing requirements.
• Observes, as needed, testing at CSPs.
• Assist site(s) in assessing technical abilities and for formal planning activities.
• Liaises with formulations, manufacturing, quality and regulatory counterparts to develop plans and protocols for drug product development
• Performs laboratory investigations:
• Investigates and/or reviews CSP out-of-specification/out-of-trend (OOS/OOT) for scientific soundness and completeness.
• Assesses performance of CSP laboratory for accuracy and technical expertise.
• Other Duties as assigned.

Education and Experience

• M.S. in Chemistry or related field. Ph.D. preferred.
• Targeting 8 years’ experience in progressively responsible roles with a focus on analytical development techniques for finished drug products with 5 years’ in a leadership role required.
• Experience authoring technical reports and CMC sections for regulatory filings.
• Related experience should include hands-on experience in at least one of the following analytical chemistry techniques: chromatography, dissolution and/or spectroscopic techniques. Experience with oversight management of CSP analytical laboratory preferred.
• An equivalent combination of relevant education and applicable job experience may be considered.

Key Skills:

• Strong understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH guidance’s, 21 CFR Part 211, 21 CFR Part 11).
• Working knowledge of United States Pharmacopeia (USP) and European Pharmacopeia (EP).
• Demonstrated problem solving abilities.
• Strong organizational and documentation skills.
• Demonstrated verbal and written communication skills.
• Ability to manage change in a dynamic environment.
• Strong understanding of analytical methods required for testing drug products and intermediates developed for small molecules and peptides
• Knowledge in testing