Associate Director Analytical Development Drug Product
Posted on 3/27/2024
Acadia Pharmaceuticals Inc.

501-1,000 employees

Develops therapies for central nervous system disorders.
Company Overview
Acadia Pharmaceuticals Inc. stands out as a leader in the healthcare industry with over 25 years of experience, particularly noted for developing the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. The company's culture is characterized by a dedicated team of "care-ageous warriors" who are committed to improving the lives of patients and their families. Acadia's competitive edge lies in its robust late-stage development efforts focused on dementia-related psychosis, negative symptoms of schizophrenia, and Rett syndrome, as well as early-stage clinical research exploring novel approaches to pain management, cognition, and neuropsychiatric symptoms in central nervous system disorders.
Biotechnology

Company Stage

N/A

Total Funding

$813.4M

Founded

1993

Headquarters

San Diego, California

Growth & Insights
Headcount

6 month growth

6%

1 year growth

19%

2 year growth

20%
Locations
Princeton, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Lab & Research
Interdisciplinary Research
Life Sciences
Requirements
  • S. in Chemistry or related field. Ph.D. preferred.
  • 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.
  • Hands-on experience in at least one of the following analytical chemistry techniques: chromatography, dissolution and/or spectroscopic techniques.
  • 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.
  • Ability to travel up to 20% of the time both domestically and internationally.
Responsibilities
  • 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.
  • 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.