Essential Functions:

• Responsible for all deliverables of small molecule raw material method qualification/validation used in intermediates, DS and DP for various projects in the Vaxcyte pipeline.
• Contribute to and implement the high-level method qualification and validation strategy decided by CMC executive team. Accountable and responsible for implementing the detailed method qualification and validation strategy with the CMOs and CTLs.
• Collaborate with Analytical Development and interface with key stakeholders to determine when a small molecule raw material method is suitable for method validation and transfer. Review and evaluate method development data, reports, and documents to be transferred to CMOs, provide technical and compliance feedback to internal and external stakeholders who have developed the analytical methods.
• Collaborate with CDMOs to design an effective method validation plan, and lead method validation activities to ensure campaign readiness. May need to author method validation protocols and reports.
• Review and approve small molecule raw material test methods, method validation and/or method transfer protocols and reports, and responsible for the accuracy and compliance of these documents. The average number of documents to be reviewed per week is about 30.
• Accountable for execution of method implementation, validation, and transfer and responsible for supportive processes including sample planning, scheduling, documentation, compliance / technical review and scientific interpretation of data to ensure the successful validation / transfer of methods.
• Responsible for quality event management (deviations, investigations, change control) related to method qualification / validation.
• Manage outsourced GMP testing at CDMOs.
• Support audit, inspections, and health authority responses.
• Guide and work with others to identify opportunities for continuous improvement and implement solutions. 

Requirements:

• PhD in Chemistry, Analytical Chemistry, or related field with 5+ years relevant industry experience; MS or BS with 10+ years of industry experience in Pharma / Biotech industry required.
• Demonstrate sound decision-making skills and exhibit good judgment. Make decision with an understanding of the strategic context and short- and long-term impact of decisions on other departments or functional areas.
• Successful track record of analytical method validation / transfer, and trouble shooting.
• Have solid understanding of principles of various analytical technology used for analysis of small molecule raw materials.
• Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards.
• Ability to manage project resource requirements (material, manpower, time, etc.), and to elevate relevant issues to analytical lead and line-management.
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to analytical method validation for small molecule raw materials, and retest period.
• Demonstrate ability of applying regulatory guidance to formulate practical solutions and strategy for phase appropriate analytical method validation and transfer with a focus on small molecule raw materials.
• Ability to work globally with CMOs in different countries and continents.
• Self-starter and resourceful problem solver, and able to move up learning curve independently and map out intermediate milestones to achieve project goals.
• Experience in IND, NDA and BLA submission is highly preferred.
• Extensive technical writing experience in drafting analytical method validation and transfer protocols, reports, and method SOPs.
• Strong interpersonal skills and ability to communicate effectively both verbally and in written formats.
• Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.