Team Lead, Microbiology

Position Overview

Located at our large molecule headquarters in RTP, North Carolina, the Team Lead will be the first hire for the Microbiology team and will play a critical role in building the function from the ground up. This position requires a hands-on builder who can establish laboratory workflows, develop team capabilities, define operating expectations, and help scale the Microbiology department while supporting client and business needs. The Team Lead will oversee resource allocation, including personnel, equipment, space, and operating resources. The Team Lead will provide operational management in consultation with the department director and will be responsible for implementing Quality Management and HSE requirements within their area. The Team Lead serves as the Subject Matter Expert (SME) for the Microbiology team supporting bioburden testing, microbial limits testing, sterility testing, endotoxin testing, microbial identification, environmental monitoring, and other compendial and advanced microbiological methods. This position is part of the Large Molecule and Advanced Therapy Medicinal Products Services organization and operates in a Good Manufacturing Practices (GMP) laboratory environment.

Please note that this is a fullyonsiteposition and requires regular, in-person attendance at the designated work location. Remote and hybrid work arrangements are not available for this role. The anticipated salary range is upto$125,000 annually, with the final offer determined based on factors such as education, relevant experience, skills, and overall qualifications.

Critical Performance Areas

1. Supervises Microbiology activities and serves as SME. Troubleshoots assays as needed.
2. Manages training, development, and coordination of daily laboratory tasks for the team.
3. Brings hands-on experience implementing, troubleshooting, and supporting microbiology techniques and methods, including but not limited to:
   • Sterility testing within an isolator, including traditional and rapid methods aligned with USP <71>.
   • Kinetic endotoxin testing, including BET and recombinant Factor C methods, using 96-well plate readers and multi-cartridge systems aligned with USP <85>. 
   • Microbial enumeration (TAMC/TYMC) and in-process/rapid bioburden testing aligned with USP <60>, <61>, and <62>.
   • Environmental monitoring
   • Growth promotion testing
   • Rapid microbiological methods
   • Media fill qualification and aseptic process simulation support 
   • Microbial identification using genetic sequencing and related organism classification procedures.
4. Ensures on-time testing and delivery of analytical results to clients.
5. Communicates effectively with clients and provides scientific expertise to projects. 
6. Has operational leadership of the team.
7. Ensures adherence to HSE. 
8. Participates in forecasting and budgeting discussions. 
9. Responsible for personnel management and development. 
10. Seeks out continuous improvement opportunities and resource efficiency.
11. Provides LIMS support and guidance as needed. 
12. Provides guidance for routine and feasibility studies, method developments, improvements of methods, quality control tasks as well as validations and verifications of methods together with the team for Solvias.
13. Supports Microbiology staff as well as project managers in technical, methodological, organizational, and financial aspects of requests for quotations, quotation preparation, acquisition and customer support.
14. Follows GMP protocols and procedures as applicable.
15. Ensures Laboratory maintenance
16. Participates in longer-term planning of equipment resources.