Manager, QC Microbiology - EM/UM 896 (Contract)

The Environmental Monitoring and Utilities Monitoring Technical support role will provide technical support for EM/UM team as a Subject Matter Expert (SME). This role will serve as a key resource within the organization, providing technical expertise in the areas of EM/UM sampling, testing, aseptic processing, and contamination control in accordance with regulatory standards.  This role reports to the Associate Director of Quality Control in Cell and Genetic Therapies (VCGT). 

• →Demonstrates a strong understanding of sampling and microbiological testing methodologies including but not limited to EM, UM, Bioburden, Endotoxins, Sterility, Gram Stain, and Identification program per relevant regulatory standards
• →Hands-on experience in the handling of microbiology lab instruments i.e. Vitek, Endosafe, BacT, MALDI-TOF, Isolator
• →Organize, plan, and support team members with technical questions and problem-solving to ensure group efficiency and accountability
• →Ensure compliance with current Good Manufacturing Practices (cGMP), as well as Health, Safety, and Environmental policies per Vertex standards
• →Provide subject matter expertise in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
• →Manages deviations and Corrective and Preventative Action (CAPA) implementation associated with Microbiological methodologies
• →Support laboratory inspections and audits, including addressing follow-up actions and ensuring continuous improvement
• →Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure alignment and effective communication between teams
• →Provide guidance in drafting EM/UM Trend Reports
• →Provide technical guidance to EM/UM analysts in performing document revisions and other EM/UM related projects
• →Draft studies/protocols/risk assessments as needed to support EM/UM operations
• →Assist with document revisions

• Extensive knowledge and experience of Quality Control methods and compendial requirements including but not limited to (Sterility, Endotoxin, Environmental monitoring, ID, APS/PAQ processes)
• Strong understanding of Aseptic processing and contamination control strategies in manufacturing facilities
• Extensive experience working in a GMP environment
• Strong communication and scientific writing
• Strong project management skills
• Experience with electronic systems such as LIMS and Quality Management Systems (Veeva) preferred

• Bachelor’s degree in Microbiology or related field.
• A minimum of 7 years of industry experience in Microbiology in a Biotechnology and/or Cell and Gene therapy organization.