Director, Formulation Development

The Director Formulation Development leads formulation primary packaging and manufacturing process development across Acadias portfolio of drug candidates from early development through commercialization. This role provides technical leadership for externalized drug product development across oral solid liquid and injectable dosage forms with a primary focus on oral solid dosage forms. The position is responsible for managing Contract Service Providers (CSPs) resolving complex technical issues and advancing manufacturing process technologies that support clinical supply process validation and lifecycle management. This role plays a key part in reducing development risk improving execution and accelerating program progression.

• Design and develop pharmaceutical formulations and manufacturing processes to support clinical development registration and product launch
• Evaluate and qualify Contract Service Providers (CSPs) to support development scale-up and commercialization and manage related supplier agreements as needed
• Lead and oversee the development and scale-up of clinical formulations and finished dosage forms at CSPs serving as on-site technical support when required
• Plan and direct scientific and technical activities including data interpretation evaluation of results development of conclusions and preparation of technical reports and presentations
• Partner with clinical supply management to define supply requirements and align CSP manufacturing schedules to ensure uninterrupted availability of clinical trial materials
• Conduct risk assessments of manufacturing processes and products at key development milestones and drive resolution of findings with relevant CSPs
• Author and review technical reports and development documentation to support regulatory submissions including review of MBRs BPRs and CSP-generated reports
• Collaborate with analytical manufacturing quality and regulatory teams to develop plans and protocols for drug product development and lifecycle management
• Ensure compliance with cGMP and applicable GxP requirements and support CSP readiness for health authority and pre-approval inspections
• Perform other responsibilities as assigned

• Advanced degree in Pharmaceutical Sciences Chemistry Chemical Engineering Materials Science or a related field required; an equivalent combination of education and relevant industry experience may be considered. Minimum of 10 years of progressively responsible experience in formulation and manufacturing process development including leadership responsibilities. Proven success in formulation and dosage form development with experience authoring technical reports and CMC sections for regulatory submissions.
• Deep understanding of dosage form formulation primary packaging manufacturing process development scale-up optimization and validation
• Demonstrated success in oral solid dosage form development of new chemical entities
• Strong knowledge of cGMP requirements and experience supporting regulatory filings including NDAs or other marketing authorization applications
• Proven ability to manage external development and manufacturing partners including CROs CMOs and CSPs
• Strong written and verbal communication skills with the ability to translate complex technical information for cross-functional audiences
• Demonstrated leadership influence and resource alignment across functions to achieve development and organizational goals
• Flexibility to travel domestically and internationally

While performing the duties of this job the employee is regularly required to stand walk sit use hands to handle or feel objects reach with hands and arms climb or balance stoop kneel crouch and see speak or hear in a standard office environment and independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. Ability to travel domestically and internationally is required.

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