Senior Manager, Microbiology Support – Global ASAT
Location
California
Posted
4 days ago
Salary
$166K - $194K / year
Seniority
Senior
Job Description
Senior Manager, Microbiology Support – Global ASAT
Vaxcyte
• 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.
Job 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.
- 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
- The compensation package will be competitive and includes comprehensive benefits and an equity component.
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