Sterility Testing Laboratory Manager

Description

Job Description An opportunity has arisen for a Sterility Testing Laboratory Manager within the Quality Control department in a pharmaceutical manufacturing environment governed by Good Manufacturing Practice (GMP) regulations. This position will lead and ensure the comprehensive operation of the associated sterility and microbiology testing laboratory, guaranteeing reliable, timely results compliant with Good Manufacturing Practices (GMP), pharmacopoeial requirements, and internal procedures. The role will manage resources, facilities, systems, and continuous improvement initiatives required to optimize the laboratory’s operational status. Its scope includes membrane filtration and direct inoculation sterility testing; interpretation, documentation, and reporting of results; and management of personnel, capacity planning, materials, culture media, reagents, reference strains, equipment, and classified areas. Regular presence in laboratory areas is required, and access to classified areas—where applicable—must comply with gowning and qualification requirements. Availability to respond to critical incidents, audits, inspections, or operational needs outside standard working hours may be required. What You Will Do You will bring energy, expertise, innovation, and leadership to accomplish the following: * Ensure GMP compliance and quality governance: execute activities in accordance with GMP, current pharmacopoeias, marketing authorizations, and internal procedures; maintain the laboratory in constant readiness for audits and inspections; lead the response to and closure of observations; and plan, prioritize, and supervise sample receipt, test execution, incubation, result reading, data review, and report issuance within agreed timelines. • * Manage laboratory controls and operational continuity: establish controls for culture media, reagents, reference strains, materials, and consumables—including receipt, release, growth promotion, storage, expiry, and inventory; manage capacity and operational continuity by anticipating workloads, constraints, maintenance schedules, and contingencies. * Ensure facility integrity, environmental control, and contamination prevention: guarantee that testing is conducted under appropriate aseptic conditions and that facility design, personnel and material flow, cleaning, and disinfection minimize contamination risk; oversee the environmental and personnel monitoring program—including its limits, alerts, actions, trends, and responses to excursions. * Manage results, deviations, investigations, methods, and equipment: promptly assess and escalate events involving positive, atypical, or out-of-specification results; lead or supervise scientifically sound investigations into sterility failures, deviations, environmental excursions, and laboratory errors; ensure method transfer, verification, validation, or suitability prior to routine use and maintain validated status; ensure equipment and computerized system qualification, calibration, preventive maintenance, and fault management. * Guarantee data integrity, change control, and continuous improvement: ensure electronic records meet data integrity requirements for access, traceability, review, and retention; evaluate and approve—per delegated authority—changes to methods, equipment, facilities, systems, suppliers, materials, and monitoring programs prior to implementation; drive simplification, digitalization, automation, and new technologies without compromising regulatory compliance or microbiological control. * Lead people, safety, biosafety, and sustainability: define team structure, assign responsibilities, and ensure sufficient capability for operational workload and criticality; select, train, qualify, and re-qualify personnel in aseptic technique, gowning, methods, safety, GMP, and data integrity; set objectives, monitor performance, develop competencies, and foster leadership, collaboration, and individual accountability; ensure compliance with occupational safety, biosafety, industrial hygiene, and biological waste management requirements; promote safe practices and incident reporting. What Skills You Will Need **To succeed in this role, you must have:** * A university degree in Microbiology, Biology, Pharmacy, Biotechnology, Biochemistry, or a related scientific discipline, with relevant experience in a GMP-regulated pharmaceutical microbiology laboratory. * Demonstrated experience in team leadership, operational planning, quality investigations, and quality decision-making. * Solid knowledge of aseptic technique, classified facilities, environmental monitoring, compendial methods, validation, data integrity, and risk management. * Ability to communicate effectively in both Spanish and English within a technical and regulated environment. Minimum B2 level required. * Visible leadership and people development; clear communication, influence, and cross-functional collaboration. * Rigor, attention to detail, and strong documentation discipline. * Root cause analysis and structured problem-solving skills. * Planning, prioritization, and resource management capabilities, including the ability to handle pressure, ambiguity, and critical situations. * Results orientation and commitment to continuous improvement. Experience in regulatory inspections, isolators, LIMS, microbial identification, and continuous improvement initiatives is highly desirable. Why Join Us? As a company, we are committed to keeping patients at the center of everything we do and to developing solutions and treatments for some of the world’s most complex healthcare needs. We take pride in being a company that values diverse, talented, and committed individuals. The fastest way to drive innovation is when diverse ideas converge in an inclusive environment. So, if you are ready to contribute your expertise and leadership in a technically rigorous, highly regulated, and continuously improving environment, apply today. **Required Skills:** Aseptic Handling, Biopharmaceuticals, cGMP Regulations, GMP Laboratory, Laboratory Operations, Manufacturing Quality Control, Microbiology, Pharmaceutical Quality Control (QC), Quality Systems Compliance, Root Cause Analysis (RCA) **Preferred Skills:** Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck Co., Inc., Rahway, NJ, USA, also known as Merck Sharp Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre\-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Not Applicable **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 09/3/2026\*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date. **Requisition ID:** R411154