Senior specialist QC Microbio

ph3Overview /h3pThe QC Microbiology Senior Specialist is responsible for the coordination, oversight, and execution of QC Microbiology activities supporting the release of Drug Substance (DS), Drug Product (DP), In-Process Controls (IPC), Environmental Monitoring (EM), Utility Monitoring, and microbiological testing performed at the QC Bioplant. /ppThe QC Microbiology Senior Specialist ensures the compliant planning, execution, review, approval, and reporting of microbiological activities in accordance with GMP requirements and defined timelines. He/She acts as the subject matter expert (SME) for microbiological methods and testing, including Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, Utilities Monitoring, and microbiological method verification, validation, and transfer activities. /ppThe QC Microbiology Senior Specialist serves as the primary point of contact for Quality Assurance, Manufacturing, Supply Chain, Engineering, Validation, Warehouse, External Laboratories, and other Quality Control functions for the microbiological activities under his/her responsibility. /ppIn addition, the QC Microbiology Senior Specialist owns and drives quality records (deviations, investigations, CAPAs, change controls), provides technical leadership and coaching within the laboratory, contributes to continuous improvement and automation initiatives, and supports regulatory inspections and audits.(AD1.1) /ph3Key Responsibilities /h3ulliPlan, coordinate, and prioritize QC Microbiology laboratory activities to ensure timely support of production and batch release activities. /liliPerform and/or oversee microbiological testing activities including Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, and Utilities Monitoring. /liliDefine, organize, and coordinate microbiological sampling plans and testing strategies for environmental and utility monitoring programs. /liliReview, approve, and trend microbiological data, internal and external analytical results, ensuring compliance with GMP requirements and predefined lead times. /liliAct as Subject Matter Expert (SME) for microbiological testing methods, specifications, method suitability, method verification, validation, and transfer activities. /liliLead microbiology-related implementation activities for new products, methods, equipment, and technologies, serving as the interface between Analytical Transfer Validation and QC Microbiology. /liliDefine and maintain microbiological specifications and testing strategies in compliance with applicable Pharmacopoeias (USP, Ph. Eur., JP), regulatory expectations, and internal requirements. /liliOwn and lead quality events associated with microbiological activities, including deviations, laboratory investigations, root cause analyses, CAPAs, and change controls. /liliCollaborate cross-functionally with QA, Manufacturing, Engineering, Validation, Supply Chain, Warehouse, and external laboratories to ensure efficient communication and issue resolution. /liliPerform thorough review and approval of analytical documentation, raw data, calculations, laboratory records, reports, and electronic data to ensure data integrity and compliance. /liliAuthor, review, approve, and maintain SOPs, Work Instructions, protocols, reports, specifications, risk assessments, and quality documentation. /liliSupport laboratory inspection readiness and actively contribute to regulatory inspections, customer audits, internal audits, and responses to observations. /liliMonitor laboratory performance through Key Performance Indicators (KPIs), identify trends, and propose actions to improve quality, compliance, efficiency, and turnaround times. /liliContribute to the development, implementation, and optimization of laboratory digitalization and automation initiatives. /liliProvide technical guidance, coaching, and training to technicians and junior laboratory staff. /liliSupport management of laboratory equipment, consumables, reagents, standards, maintenance, qualification, and calibration activities. /liliAct as a role model for GMP compliance, data integrity, quality culture, and business ethics. /liliContribute to resource planning, laboratory organization, and continuous improvement initiatives. /liliAct as delegate for the Manager QC Microbiology when required. /liliPerform additional activities as assigned by management. /li /ulh3Education and Experience /h3ulliMinimum Bachelor's degree in Microbiology, Biotechnology, Life Sciences, or related scientific discipline with a minimum of 5 years of relevant experience in QC Microbiology within a GMP-regulated pharmaceutical or biotechnology environment. /liliStrong hands-on experience with Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, and Utilities Monitoring. /liliDemonstrated experience with microbiological method verification, validation, transfer, and lifecycle management. /liliDeep knowledge of microbiological testing, aseptic techniques, and applicable Pharmacopoeias (USP, EP, JP). /liliStrong understanding of GMP regulations, Data Integrity principles, and quality risk management. /liliProven experience leading investigations, root cause analyses, CAPAs, and change controls. /liliExperience supporting regulatory inspections and quality audits. /liliStrong problem-solving, analytical thinking, and decision-making skills. /li /ulh3Knowledge, Skills, Abilities /h3ulliHigh degree of autonomy, accountability, and ownership. /liliStrong organizational and planning skills. /liliAbility to coordinate activities and manage multiple priorities simultaneously. /liliExcellent communication and stakeholder management skills. /liliStrong team‑player mindset with demonstrated ability to influence cross‑functional teams. /liliProactive, pragmatic, and continuous improvement oriented. /liliAbility to coach and mentor laboratory personnel. /liliFrench: Fluent. /liliEnglish: Advanced (minimum C1). /liliProficiency with LIMS, electronic quality systems, and Microsoft Office applications. /li /ulh3Work conditions /h3ulliWork on weekends and outside standard working hours may be required. /li /ulh3Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /h3h3We Respect Your Privacy /h3pLearn more at: /ppThe Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. /ppDuring the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. /ppYou may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. /ppYou can learn more about Incyte’s data protection practices here. 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