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Senior Manager, Microbiology Support for Global ASAT

San Carlos, California, United States

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. 
 
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
 
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
 
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
 
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
 
*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

Vaxcyte is looking for an energetic and talented individual to join our Analytical Science and Technology (ASAT) as a Sr. Manager. The position will be an integral part of the team responsible for cGMP-compliance in routine operations for all phases of clinical development for Vaxcyte’s PCV product to commercialization. The primary responsibility will include supporting the microbiological quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations. The ideal candidate will apply technical expertise, strong cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches. The ideal candidate will have expertise in microbiological assays (bioburden, endotoxin, sterility and culture purity) as well as understanding or experience with aseptic manufacturing (EM, smoke studies, media fills, etc.).

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.
  • Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
  • Ability 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.
Reports to: Senior Director, Global Analytical Sciences and Technology (ASAT) Lead
 
Location: Open to Remote; San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $166,000 – $194,000 (SF Bay Area). Salary ranges for non-California locations may vary.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

 

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