4+ years of microbiology laboratory experience, preferably with rapid microbiological methods
Familiarity with cGMP QC laboratory practices
Strong communication skills, both written and verbal
Ability to present technical data to senior leadership
Experience in environmental monitoring and investigation writing
Responsibilities
Act as microbiology subject matter expert in investigations and change controls
Author and approve microbiology methods, ensuring compliance with regulatory standards
Analyze data to address contamination control issues
Train QC and manufacturing teams on contamination control methods
Execute microbiology procedures related to method lifecycle activities
Perform routine and non-routine QC testing as required
Collaborate with cross-functional teams across departments
Benefits
Contribute to critical cGMP operations
Engage in a collaborative, cross-functional work environment
Opportunity to lead training initiatives
Involvement in method lifecycle activities
Address real-world contamination control challenges
Full Job Description
Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
Author, review, approval, and final authorization of microbiology methods (test results and records, test methods) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
Analyzes data to identify and resolve contamination control issues, maintains documentation, and collaborates with cross-functional teams to support and improve contamination control strategies.
Provide training to QC and MFG as a contamination SME: develop training approach, training documents and provide training for new methods.
Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
Ability to prepare technical data and present to senior leadership.
WHAT YOU WILL BRING
Bachelor's degree in Biology (Microbiology)
4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
Excellent/Effective written and verbal communications skills.
Prepare technical data and present to senior leadership.
Escalate issues professionally and on a timely basis.
