Director/Sr. Director Pharmaceutical Technology
The Director/Senior Director, Pharmaceutical Technology position is responsible for leading and executing Phase 3 to commercial drug product (bulk and packaged solid oral dosage NME products) development plan, characterization for tech transfer and validation for commercialization.
- Lead and manage all activities related to Phase 3 CMC drug product development activities and tech transfer, ensuring that (1) appropriate scientific and technical standards are established; (2) data are available to support regulatory filing; and (3), in partnership with Quality, quality controls are implemented and followed.
- Provide technical and project leadership to ensure success through to commercialization.
- Lead and manage CMO activities for late stage development (e.g. tech transfer, scale-up/process development/optimization and from 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 identified 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 GMP; 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.
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering (or related discipline) with 15+ years of industry experience, or demonstrated track record of successfully validating solid oral dosage drug products.
- MS degree in related scientific discipline with 20+ years industry experience.
- Well-versed and demonstrated successes in the application of QbD principles.
- Demonstrated success in shepherding late phase oral drug product through pharmaceutical development characterization to validation, pre-approval inspection and commercial manufacturing.
- Excellent knowledge in FDA and EMA regulations and cGMP, 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.
- Have strong organizational and planning skills to determine appropriate resources for resolution of problems.
- Ability to travel domestically and internationally up to 25% of the time.
Principia Biopharma, Inc. is an equal opportunity employer.