Senior Manager, Microbiology Support for Global ASAT

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. 7+ years of experience in Pharma / Biotech industry in aseptic manufacturing or microbiology required. Other combinations of education and/or experience may be considered.
• 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), writing and approving Exception Reports (ERs), and driving CAPA (Corrective and Preventive Actions) implementation; displaying excellent organization, problem solving, and strategic planning skills.
• 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).
• Able to apply the knowledge and understand/gain in depth understanding of variety of methods in place for components used in Vaxcyte vaccine programs.
• Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards.
• Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Able to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
• Able to work globally with CMOs in different countries and continents.
• Self-starter and resourceful problem solver, able to move up learning curve with some guidance and map out intermediate milestones to achieve personal goals.