Senior Manager, Microbiology Support – Global ASAT

🕒 May 21

🏄 California – Remote

🏄 California – Remote

💵 $166k - $194k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• 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

• 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.