Microbiology Manager

Would you like to join a global aseptic manufacturing company as a Microbiology Manager of their site in the greater Charlotte, NC area? Our client is looking for a strong leader who can support the growing Microbiology team and work with sterile injectables, vials, and pre filled syringes. The Microbiology Manager will be responsible for:

• Reading, review and trend analysis of environmental monitoring and water test data
• Contamination Control Strategy, Media Fills, Qualification for sterilizers
• Developing and validating microbial test methods for bioburden, sterility, liquid particle counts and endotoxin test
• Microbiological testing of raw-materials, in-process materials and finished products
• Response preparation for internal and external audit observation. Implementation of CAPA in micro lab
• Review of regulatory audit observations at other sites and ensure compliance in microbiology department of the site
• Interacting with site QA and inform about failures/ OOS / OOT / incident / Non compliances
• Providing support in Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site

Education/Experience Required

Education:

• Bachelor degree in Pharmaceutical Sciences, Microbiology or equivalent required. Master’s degree in microbiology or equivalent, preferred

Experience:

• 5 – 7 years of Pharmaceutical experience (formulation facility).
• Background of functions of Microbiology.
• Experience working at an injectable facility.
• Experience supporting audits.