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) as 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.