Associate Director, Formulation Sciences

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients and contribute to the development of commercial supplies through process validation.

Requirements

• PhD in pharmaceutical sciences, or chemical engineering with a minimum of 8 years or MS/BS with 15+ years of industry experience
• Proven track record on drug product process validation, scale up and post-approval changes and commercial manufacture
• Must have experience on solid dosage form (tablet) late-stage process validation through commercialization
• A strong understanding and knowledge of CGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required
• Effectively manage late-stage validation, post-approval changes and commercial manufacture activities within a virtual working environment
• Experience with implementation of QbD strategies and DoE approach during drug product Life-cycle management
• Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals
• Mastery of current ICH guidelines and related industry guidelines and practices
• Ability to author and review relevant development reports as well as regulatory dossiers

Responsibilities

• Responsible for drug product process validation activities and lead Scale up and post-approval changes (SUPAC) and routine commercial manufacturing
• Identify critical process parameters based on the risk assessment and understanding the impact of material attributes and process parameters on critical quality attributes. Implement appropriate process controls to ensure delivery of consistent batch product quality
• Draft, coordinate, and execute validation protocols, perform data analysis, author/review and approve process validation reports with consistent and effective communication with other functions
• Provide support to routine process validation studies, assisting with product technology transfers or lifecycle management changes such as process improvement, addition of secondary API and manufacture site change etc
• Perform technical review of drug product manufacture deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for drug product lot release (assess deviations and process changes)
• Work closely with other team members and cross-functionally with quality assurance, analytical/QC, chemical development, supply chain, and project management team to achieve all project deliverables
• Provide leadership and technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc
• Mastery of statistical analysis software, such as JMP or similar
• Perform process capability analysis, identify risk, and make recommendations for process improvement
• Represent the drug product group as a Subject Matter Expert in audits and regulatory inspections
• Support authoring of the relevant technical sections of regulatory filings