Sr. Manager/ Associate Dir., Late Stage Pharmaceutical Devlopement

Job Summary:

The Sr. Manager/Associate Director, Late Stage Pharmaceutical Development position is responsible for leading and executing late stage drug product development efforts including risk assessment, scale-up, optimization, and all stages of process validation and commercial preparedness

Responsibilities:

• Lead and manage all activities related to late stage CMC small molecule drug product development, ensuring the appropriate scientific, regulatory and quality standards are implemented and followed.
• Provide technical and project leadership to ensure success through the commercialization process
• Lead and manage CMO activities for all stages of drug product development for small molecules with a particular emphasis on late stage development (e.g. tech transfer, scale-up/process development/optimization and all stages of process validation through commercialization)
• Oversight of contract manufacturing organizations conducting process characterization studies according to the principles of Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identify proven acceptable ranges (PARs) of critical process parameters (CPPs), including identification of edge-of-failure (EoF), characterization of input materials (active pharmaceutical ingredients and excipients) to identify critical quality attributes (CQAs). Provide direction to the CMOs in terms of design of formulation characterization studies during clinical development and design of registration strategies for commercial supply chain(s), review and approval of release testing data, as well as stability data. Review of quality control testing and certification that batches meet specifications and in compliance with cGMP; and document and institutionalize all development activities as source materials for regulatory filings
• Author and review validation related documents and process development reports
• Actively contribute to writing key pharmaceutical development sections of regulatory documents IND/IMPD/NDA

• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering
• Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs

Requirements:

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering (or related discipline) with 12-15 years of industry experience
• MS degree in Chemical Engineering (or related scientific discipline) with 15+ years industry experience
• Well-versed and demonstrated successes in the application of QbD principles
• Demonstrated success in shepherding late phase oral solid dosage drug product through pharmaceutical development characterization to validation, pre-approval inspection and commercial manufacturing
• Excellent knowledge in FDA and EMA regulations, ICH guidelines (Q8, Q9, Q12)
• Highly skilled in solid oral dosage formulation and process development for immediate release and modified release dosage forms
• Extensive experience managing contract manufacturing organizations is North America, Europe and Asia
• Strong leadership, interpersonal, communication, collaboration and problem solving skills along with strengths in delivering results on firm deadlines in support of development programs
• Thinks critically and creatively and is able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills
• Ability to travel domestically and internationally up to 30% of the time

Principia Biopharma, Inc. is an equal opportunity employer