Senior Manager, Microbiology Support for Global ASAT

Summary:

Vaxcyte is looking for an energetic and talented individual to join our Analytical Science and Technology (ASAT) ss a Sr. Manager. The position will be an integral part of the team responsible for cGMP-compliance in routine operations for all phases of clinical development for Vaxcyte’s PCV product to commercialization. The primary responsibility will include supporting the microbiological quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations. The ideal candidate will apply technical expertise, strong cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches. The ideal candidate will have expertise in microbiological assays (bioburden, endotoxin, sterility and culture purity) as well as understanding or experience with aseptic manufacturing (EM, smoke studies, media fills, etc.).

Essential Functions:

• Serve as the technical expert for QC microbiological assays.
• Support the authoring and review internal SOPs related to microbial Quality Control policies and procedures. Also support the authoring of BLA sections as required.
• Responsible for quality event management (deviations, investigations, change control) related to microbiology QC and aseptic manufacturing operations.
• Manage outsourced cGMP and characterization testing supporting lot release.
• Collaborate with Analytical Development, Quality Control, and Product Development (and MSAT) and interface with key stake holders to understand methods being performed onsite and at CMOs.
• Apply technical and compliance expertise to the review of test methods and in-process/release documentation and provide technical and compliance feedback to internal and external stakeholders who have developed/verified the microbiological methods.
• 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: 

• Degree(s) in Microbiology, Biology, Biochemistry, or related discipline with a minimum of 7+ years of relevant experience for Ph.D., 9+ years for M.S./M.A., or 11+ years for B.S./B.A. Other combinations of education and/or experience may be considered. 7+ years of experience in Pharma / Biotech industry in aseptic manufacturing or microbiology required. Other combinations of education and/or experience may be considered.
• Understanding of various analytical methodology principles and experience with GMP release testing. Knowledge of microbial control methods (e.g. Bioburden, Endotoxin, Sterility, Growth Promotion).
• Previous experience in analytical method verification, development, validation and transfer is highly desirable.
• Experienced leading investigations into microbiological non-conformances (deviations, out-of-specification results), writing and approving Exception Reports (ERs), and driving CAPA (Corrective and Preventive Actions) implementation; displaying excellent organization, problem solving, and strategic planning skills.
• Solid understanding of relevant cGMPs, FDA, EU, and ICH regulatory guidelines as applicable to QC operations/aseptic processing/manufacturing sterility assurance, and/or compendial methods (USP/EP/JP).
• Able to apply the knowledge and understand/gain in depth understanding of variety of methods in place for components used in Vaxcyte vaccine programs.
• Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards.
• Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.
• 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.
• Self-starter and resourceful problem solver, able to move up learning curve with some guidance and map out intermediate milestones to achieve personal goals.