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 fully onsite position 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 up to $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.

Essential Job Functions

• Ensures compliance with GMP regulatory requirements and SOPs. 
• Ensures compliance with USP, EP, JP, FDA, EMA, and applicable microbiological testing requirements. 
• Investigates deviations, nonconformities, OOS results, change controls, and other quality events in accordance with GMP requirements. 
• Trains scientists and analysts in the team as needed.
• Contributes to process improvements for effective and efficient workflows in the lab. 
• Works collaboratively with other Team Leads, cross-functional teams, and customers.
• Demonstrates strict aseptic technique in sample handling, testing, and laboratory execution.
• Performs microbiological testing of raw material, in-process, and finished product samples, including microbial examination, in-process bioburden, kinetic endotoxin, sterility, sub-visible particulate matter, microbial in-use studies, and media fill qualification support.
• Handles, cultures, and maintains microorganisms as required for compendial testing, growth promotion, microbial identification, and laboratory controls. 
• Examines physiological, morphological, and cultural characteristics using microscopy and other relevant equipment to identify and classify microorganisms in test articles.
• Manages sample incubation, plate reading, result reporting, and accurate completion of GMP documentation and reviews as assigned.
• Recognizes deviations from procedures and supports investigations, quality events, and continuous improvement activities.

Requirements

• M.S. or Ph.D. Life Sciences with 3+ years relevant experience or B.A/B.S. with 8+ years relevant experience. 
• Prior supervisory experience. 
• Experience working in GMP or GLP environment.
• Strong experience in method development, qualification and validation of microbiology techniques and other emerging technologies.
• Client management experience in a CRO/CDMO is preferred.
• Demonstrated ability to build a new team, laboratory function, or operational capability, including establishing processes, developing talent, and creating scalable ways of working.

Other Desired Skills/Abilities

• Excellent organizational skills, ability to work independently and collaboratively in a team environment.
• Strong written and verbal communication skills.
• Strong working knowledge of aseptic technique, microbial taxonomy procedures, classes of organisms, and organism classification.
• Familiarity with GMP regulations, USP compendial requirements, and Microsoft Office applications.
• Ability to independently execute routine microbiological testing with limited supervision and perform more complex methods with appropriate oversight.
• Demonstrates sound decision-making, initiative, organization, collaboration, and the ability to drive assigned tasks to timely completion.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting. 

NOTE:  This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.