Manager, CMC Analytical Development
ESSENTIAL ROLE AND RESPONSIBILITIES
- Provide technical oversight of outsourced analytical activities to enable timely delivery of supplies for portfolio programs.
- Analyze results, solve analytical issues, and meet regulatory expectations for analytics applied to small molecule drug substances and drug products.
- Author, review and approve analytical related change controls, deviations, CAPAs, and risk assessments.
- Review and approve analytical documents such as analytical method development report, feasibility study, qualification protocol, validation protocol, transfer protocol, validation report, method of analysis, and laboratory investigation report.
- Provide on-site presence at CDMOs for audit, training, meetings as needed to achieve objectives.
- Manage tracking of analytical reference standards and impurities.
- Review stability studies for drug substances and drug products to support retest date or shelf-life.
- In collaboration with regulatory, author relevant Chemistry, Manufacturing and Controls (CMC) sections for drug substances and address Regulatory reviewer comments with data supporting responses to enable accurate and timely registrational submission.
- Flexibility to travel up to 25% domestic/international
ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE
- Ph.D. or M.S. in Chemistry with 10+ years of related pharmaceutical development experience.
- In-depth working knowledge of analytical techniques, analytical method development, method transfer, method validation and stability.
- Knowledge in biologic analytical methods is a plus.
- Ability to understand complex processes, identify knowledge gaps and propose efficient and effective solutions to issues.
- Experience in regulatory filings, specifications and controls, analytical method development and validation and the commercialization process.
- Knowledgeable of ICH guidelines and FDA Guidance related to Pharmaceutical development, validation, manufacturing and stability of drug substance and drug product.
- Experience in actively managing outsourcing to contract development and manufacturing organizations.
- Ability to work independently in a cross-functional team environment.
- Ability to manage multiple priorities and operate effectively.
- Excellent written and oral communication skills.