Senior Manager, Microbiology Support – Global ASAT

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the technical authority for QC microbiological assays.

• Assist in the creation and evaluation of internal SOPs related to microbial Quality Control policies and practices.

• Oversee quality event management concerning microbiology QC and aseptic manufacturing processes.

• Manage outsourced cGMP and characterization testing to facilitate lot release.

• Collaborate with Analytical Development, Quality Control, and Product Development while engaging with key stakeholders.

• Leverage technical and compliance knowledge to review test methods and offer constructive feedback.

• Partner with colleagues to discover opportunities for continuous improvement and execute solutions.

• Foster strong teamwork in cultivating a quality culture and shared accountability.

⛳️ Requirements

• Degree(s) in Microbiology, Biology, Biochemistry, or a related field with at least 7+ years of relevant experience for Ph.D., 9+ years for M.S./M.A., or 11+ years for B.S./B.A.

• A minimum of 7+ years of experience in the Pharma/Biotech industry focused on aseptic manufacturing or microbiology is required.

• Familiarity with various analytical methodologies and experience with GMP release testing.

• Knowledge of microbial control techniques (e.g., Bioburden, Endotoxin, Sterility, Growth Promotion).

• Prior experience in analytical method verification, development, validation, and transfer is highly desirable.

• Proven track record in leading investigations into microbiological non-conformances (deviations, out-of-specification results).

• Strong understanding of applicable cGMPs, FDA, EU, and ICH regulatory guidelines related to QC operations, aseptic processing, manufacturing sterility assurance, and/or compendial methods (USP/EP/JP).

• Results-oriented with good judgment in prioritizing attention and efforts across competing tasks.

• Highly proficient in both verbal and written communication, with the ability to engage effectively.

• Capability to work globally with CMOs across different countries and continents.

🏝️ Benefits

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