Please note that this position is based in San Diego, CA and 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

• 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 related to sterile/aseptic drug products and nasal delivered drug products.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization.
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
• Ability to travel up to 20% of the time both domestically and internationally

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. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business needs.

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