Senior Manager, Microbiology Support – Global ASAT

Vaxcyte

Senior Manager, Microbiology Support for Global ASAT at Vaxcyte, overseeing cGMP compliance in microbiological quality control activities.

Posted 5/21/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $166,000 - $194,000 per yearWebsite

About the role

Key responsibilities & impact

Serve as the technical expert for QC microbiological assays.
Support the authoring and review internal SOPs related to microbial Quality Control policies and procedures.
Responsible for quality event management 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 interface with key stakeholders.
Apply technical and compliance expertise to the review of test methods and provide feedback.
Work with others to identify opportunities for continuous improvement and implement solutions.
Provide strong teamwork in establishing a quality culture and shared accountability.

Requirements

What you’ll need

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.
7+ years of experience in Pharma / Biotech industry in aseptic manufacturing or microbiology required.
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).
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).
Result oriented; good judgment in directing attention and effort across competing priorities.
Highly skilled in both verbal and written communication with the ability to interact effectively.
Ability to work globally with CMOs in different countries and continents.

Benefits

Comp & perks

The compensation package will be competitive and includes comprehensive benefits and an equity component.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

microbiological assaysSOP authoringquality event managementcGMP testinganalytical methodologyGMP release testinganalytical method verificationmethod developmentmethod validationmicrobial control methods

Soft Skills

teamworkcommunicationjudgmentcontinuous improvementcollaborationaccountabilityproblem-solvingleadershipinterpersonal skillsglobal collaboration