Sr. Director, ASAT for QC

CMO/CRO Oversight

• Evaluate and audit CMOs for QC release testing and stability studies, provide recommendation to company CMC leadership team for QC site selection of various programs from early clinical phase to commercial.
• Ensure quality and compliance of QC activities, and accountable for timely deliverables of the analytical method transfer, implementation, and validation at CMOs/CROs, and reference standard qualification.
• Serve as decision maker for QC and reference standard program, provide clear rationale and thorough supporting data to gain the CMC team endorsement of the decisions.
• Review and approve average of 50 analytical documents weekly, responsible for the accuracy and quality of 250+ analytical QC methods, and many QC documents, ensuring that they meet regulatory and industry standards.
• Responsible to developing phase appropriate method validation strategy from phase 1 to BLA to PAS, that meets project timelines and company strategic direction.
• Lead the CMOs/CROs and internal analytical QC team to develop phase-appropriate, efficient, smart, and compliant method validation protocols, considering the specific requirements for materials, including small molecules, polysaccharides, conjugates, enzymes, proteins, and protein mixtures.
• Collaborate closely with the Analytical Development team to review method development and pre-qualification data to set appropriate method-specific validation or qualification acceptance criteria.
• Review and approve all method validation protocols and reports to ensure that they meet the highest standards of quality, accuracy, and compliance with regulatory requirements.
• Provide guidance and direction to CMO/CRO analytical team to solve issues arises during product development. Act as the primary decision maker for troubleshooting issues related to QC testing, method implementation, and validation. 

Project Planning, Alignment and Progress Monitoring

• Develop project plans, including timelines, resource and material demands, and deliverables, for analytical method implementation and validation.
• Gain alignment and buy-in from internal stakeholders, the ADQC team, project management and CMO analytical project teams.
• Ensure that project timelines and deliverables align with the company's broader project timelines.
• Once analytical projects begin, periodically review the team's progress toward the agreed project plan.
• Make necessary adjustments to ensure that projects are delivered per the agreed-upon timelines.

Strategic Leadership

• Develop a comprehensive strategy for managing analytical methods within the CMO network, continuously improving processes, and ensuring efficient coordination.
• Design and implement team structure and growth plan to meet the company short term business needs and support company long term growth plan.
• Lead, mentor, and develop a team of QC directors, managers and scientists within the analytical development and quality control department.
• Manage performance of the team to ensure alignment towards goals; set SMART goals for the team members; ensures teams have the right mix of talent and resources to meet/exceed goals.
• Establish phase appropriate reference standard program and ensure its compliance to industry guidance and HA regulations. meets compliance to health authority expectation.

Regulatory Compliance

• Collaborate with regulatory affairs and Quality Assurance to ensure that methods implemented by CMOs meet or exceed all applicable regulatory requirements.
• Ensure that deviations and CAPAs are thorough, scientifically sound and compliant. 

Requirements:

• Highly skilled, motivated, energetic, and creative leader who thrives on challenges and who is excited by the prospect of making a meaningful impact within a forward-thinking organization.
• Strong Analytical Technical Knowledge: Success in this position hinges on a deep understanding of analytical methodologies, including the ability to grasp and apply various analytical methods swiftly. A robust foundation in analytical science is essential for making informed decisions and ensuring the accuracy and quality of analytical activities.
• Adeptness in Learning: Given the broad range of molecular structures and analytical methods involved, the ability to quickly learn and adapt to new techniques and technologies is paramount. Your capacity to stay on top of principles and key details of 200+ analytical methods and constant improvements made by Analytical Development, and swiftly integrate this method knowledge into your daily decision making and problem solving is vital.
• Critical Document Review: With the responsibility to review and approve hundreds of QC documents, meticulous attention to detail and the capacity to critically assess data and reports is non-negotiable. Ensuring the highest standards of quality and compliance relies on your thorough and discerning approach.
• Strong Problem-Solving Skills: You must possess strong and pragmatic problem-solving skills to address the multifaceted challenges that arise in the CMOs’ Analytical Development and QC organization during method transfer, method qualification/validation and QC testing. The ability to navigate complex issues with innovative solutions is a cornerstone of this role.
• Good Judgment and Decision-Making: The role necessitates making critical decisions that impact product quality, compliance, and project timelines, which has direct impact on company strategic goals and milestones. Sound judgment and decision-making abilities are imperative to guide the team and ensure the company's QC and manufacturing objectives are met.

Other Requirements:

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field with 15+ years relevant industry experience; MS or BS with 20+ years of industry experience in Pharma / Biotech industry required.
• Proven track record of analytical development leadership for biologics and small molecules, experience with vaccines, carbohydrate, or conjugates is a plus.
• Extensive experience in analytical development, and experience in providing technical guidance to quality control, with at least 5 years in a senior leadership role.
• Strong knowledge of regulatory requirements and quality standards in the pharmaceutical industry.
• Proven track record of successful project management, team leadership, and strategic planning.
• Ability to collaborate effectively across functions and with external stakeholders.
• Outstanding organization and planning skills.
• Must be a strong technical leader who can guide project teams at CMOs and internal team with clear goals of implementing and validating analytical methods, with critical and skillful review and assessment of analytical methods.
• In-depth expertise in U/HPLC, CE, mass spectrometry, GC, colorimetric and other analytical technologies as applied to small molecules, polysaccharides, proteins, conjugates, and adjuvanted drug product vaccines. Skilled in analytical method development, trouble shooting, and validation for GMP lot release and stability testing.
• Excellent technical writing skills and direct experience in authoring method SOPs, validation protocols and reports, and regulatory filings.
• Ability to work in a fast-paced team environment, and to consistently meet aggressive timelines while prioritizing tasks for multiple projects.
• Strong written and verbal communication skills, and efficient in communicating to inter-disciplinary and cross-functional teams.
• Familiarity with FDA, ICH, EMA and other regulatory agency guidance associated with release and characterization assays.
• All Vaxcyte employees require vaccination against COVID-19.