The Senior Manager/Associate Director of Drug Substance Development position will report to the Senior Director of CMC and will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials and NDA readiness activities. The Sr. Manager/Associate Director, Late Stage Drug Substance Development position is responsible for leading and executing late stage drug substance development efforts including risk assessment, scale-up, optimization, and all stages of process validation and commercial preparedness.
- Lead and manage all activities related to late stage CMC small molecule drug substance 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 CMOs through late stage development activities for drug substance development for small molecules (e.g. tech transfer, scale-up/process development/optimization and all stages of process validation through commercialization)
- Oversight of contract manufacturing and research 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-factor-at-time (OFAT) and DOE studies to define 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 process development 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
- Primary author responsibility writing key drug substance sections of regulatory documents IND/IMPD/NDA
- Drive continuous improvement in the drug substance development process through technological innovation and application of first principles in process engineering
- Serve as subject matter expert in drug substance 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 Chemistry, Chemical Engineering (or related discipline) with 6 – 10 years of industry experience
- MS degree in Chemistry, Chemical Engineering (or related scientific discipline) with 10 + years industry experience
- Well-versed and demonstrated successes in the application of QbD principles
- Demonstrated success in late phase drug substance development from pharmaceutical development characterization to validation, pre-approval inspection and commercial manufacturing
- Working knowledge in FDA and EMA regulations, ICH guidelines (Q8, Q9, Q12)
- Experience managing contract manufacturing organizations is North America, Europe and Asia
- Strong leadership, interpersonal, communication, collaboration and problem-solving skill along with strengths in delivering results on firm deadlines in support of development programs
- Thinks critically and creatively and able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills
- Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA). NDA authoring experience a plus.
- Strong understanding of pharmaceutical development, quality and regulatory issues.
- Hands-on GMP experience with late phase of drug product development, as well as in-depth knowledge and full understanding of GMP requirements
- Ability to manage tasks (directly and indirectly) and variable workloads with demanding timelines.
- Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution
- Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management
- Proficiency with Microsoft software (Word / Excel / PowerPoint).
- Position requires 20% travel. Must have the ability to travel internationally.