Essential Functions:

• Review validation and transfer protocols, data, and reports for analytical assays associated with the early-phase program. Collaborate with Quality Control to set appropriate validation/transfer acceptance criteria.
• Act as the main contact within Vaxcyte QA and with external partners, fostering collaborations to support analytical requirements for Vaxcyte’s materials. Work with internal stakeholders to understand methods performed onsite and at CMOs.
• Review test methods, protocols, data, and CoAs from CMOs with technical and compliance expertise. Give compliance feedback to stakeholders who have developed the analytical methods.
• Review and manage deviations, OOS/OOT results, and perform risk assessments related to drug product testing. Support vendor management for drug product testing vendors. Act as the Analytical QA representative in internal drug product discussions.
• Accountable for execution and oversight of processes within the quality system as they apply to the early-phase program (deviations and investigations, change controls, and CAPAs).
• Support regulatory submissions and responses to health authority questions during various clinical phase filings.
• Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability.

Requirements:

• Bachelor’s degree in Biochemistry, Chemistry, or a related field with 9+ years of relevant industry experience.
• Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies.
• Experience working with biochemistry, immunoassay, or microbiological assay techniques.
• Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
• Strong written and verbal communication skills, including the ability to work effectively in cross-functional teams.
• Previous experience in validation and transfer of analytical assays is highly desired.
• Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
• Ability to work globally with CMOs in different countries and continents.
• Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
• Experience in IND, NDA, and BLA submission is preferred.