QC Analytical/Microbiology Lead

Position Overview The QC Analytical/Microbiology Lead will direct all QC analytical chemistry and microbiology activities supporting project execution and operational readiness. This role develops sampling strategies for process validation, utilities and water/WFI systems qualification, environmental monitoring, and cleaning validation, while coordinating lab activities across commissioning, qualification, PPQ, and manufacturing start-up. As the QC subject matter expert, the Lead oversees method transfer and validation, laboratory equipment and resource readiness, SOP and sampling plan development, and ensures compliance with cGMP and data integrity standards. The role also leads quality investigations (OOS/OOT/deviations/CAPAs) and serves as the primary QC representative across cross-functional teams including CQV, Manufacturing, Engineering, MSAT, Validation, and QA. Key Responsibilities Project Leadership & Operational Readiness Lead all QC analytical and microbiology sampling activities to support project execution, operational readiness, and successful milestone delivery. Develop and implement comprehensive sampling strategies for process validation, utilities qualification, water systems, WFI systems, environmental monitoring programs, and cleaning validation activities. Coordinate laboratory activities to support commissioning, qualification, validation, process performance qualification (PPQ), and manufacturing start-up activities. Identify project risks related to sampling, testing, laboratory capacity, and resource constraints, implementing mitigation plans to maintain project timelines. Ensure all testing activities align with project schedules, regulatory expectations, and business objectives. Analytical & Microbiology Technical Leadership Provide technical leadership for analytical chemistry and microbiological testing activities. Support method transfer, method verification, method qualification, and analytical method validation programs. Serve as the subject matter expert (SME) for QC analytical and microbiology operations during project execution. Review and interpret analytical and microbiological data to support qualification, validation, and product release activities. Troubleshoot technical issues and provide scientific guidance for complex testing requirements. Laboratory Readiness & Compliance Ensure laboratory readiness by overseeing: Laboratory equipment qualification and readiness Analytical and microbiological methods Standard Operating Procedures (SOPs) Sampling plans and protocols Consumables and inventory management Sample management systems Laboratory resource and testing capacity planning Ensure all laboratory activities are performed in accordance with cGMP, Data Integrity, ALCOA+ principles, and applicable regulatory requirements. Support audit and inspection readiness activities, including regulatory, customer, and internal audits. Quality Systems & Investigations Review and…