Director Drug Product Development

Director Drug Product Development

Requirements

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. Ph.D. is desirable. An equivalent combination of relevant education and applicable industry experience may be considered
• A minimum of 10 years experience in progressively responsible roles with a focus on formulation and manufacturing process development with some experience in leadership role desired
• Demonstrated success in the field of formulations and dosage form development
• Experience authoring technical reports and CMC sections for regulatory filings
• Comprehensive understanding of the drug product formulation and package development, manufacturing process development, scale-up, optimization and validation processes
• Extensive knowledge of cGMPs
• Skilled at managing CSPs
• Demonstrated verbal and written communication skills
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals
• Flexibility and ability to travel both domestically and internationally

Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline. Initiate and manage supplier contract agreements as necessary
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs. Serves as person-in-the plant at the CSP sites
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs
• Drafts SOPs as needed to support manufacturing of finished drug product and clinical trial materials (CTM)
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections
• Other responsibilities as assigned

Preferred Qualifications

• Ph.D. is desirable
• Flexibility and ability to travel both domestically and internationally