QC Microbiology Manager

PSC Biotech Corporation; Cork; Vor Ort; EUR 120.000 - 150.000; Vollzeit

Zusammenfassung

PSC Biotech Corporation is seeking a QC Microbiology Manager to lead the microbiology laboratory team responsible for testing supporting drug substance and drug product release, including environmental monitoring and trending. The role requires strong leadership, technical microbiology expertise, and coordination across QA, Manufacturing, Facilities and Regulatory affairs.

The ideal candidate will drive continuous improvement, ensure inspection readiness, and mentor staff while maintaining high

Qualifikationen

• Understand FDA and European regulatory requirements for microbiological control.
• Experience managing performance and developing team members.
• Knowledge of lean laboratory principles and continuous improvement.
• Excellent written and verbal communication with customer focus.

Aufgaben

• Lead the QC Microbiology team to operate under current cGMP standards.
• Own environmental monitoring and utilities monitoring programmes.
• Oversee investigations for out-of-specification and excursions, incl. root cause analysis.
• Coordinate QC microbiology with QA, Manufacturing, Facilities, Regulatory, and external labs.
• Develop team through training and Lean lab practices.

Kenntnisse

Leadership

Team management

Project management

Communication

Adaptability

Jobbeschreibung

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Cork
• State/Province Cork
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Role Overview

• The QC Microbiology Manager reports to the Head of QC andis responsible for leading the QC Microbiology laboratory team . The teamdelivers the microbiological testing that underpins release and monitoring ofdrug substance and drug product, including anaerobic bioburden, environmentalmonitoring, water sampling, plate reading, growth promotion and associatedtrending and reporting.
  
• It is expected that the incumbent will lead in ahigh-performing, team-based organisation, where colleagues are flexible,multi-skilled and empowered to make decisions. A high level of initiative,energy and motivation are key role requirements, alongside strongorganisational and planning skills.
  
• The incumbent must possess technical expertise inmicrobiology and aseptic operations, and demonstrate both technical andpersonnel leadership. The role provides co-ordination and alignment between QC,QA, Manufacturing, Facilities and Supply Chain so that microbiological testingand monitoring commitments are delivered in line with the site supply plan andquality capacity.
  

Requirements

Key Responsibilities

• Lead the QC Microbiology team to operate in compliancewith current cGMP standards at all times, ensuring samples are tested andresults delivered within specified timelines.
  
• Own the site environmental monitoring and utilities(water and compressed gases) monitoring programmes, including routineexecution, periodic review, quarterly reporting and trending.
  
• Provide oversight of out-of-specification, out-of-trendand excursion investigations, including microbial identification, root causeanalysis and documentation of corrective actions.
  
• Own and provide oversight for sterility testing programon site related to the Drug Product Facility onsite.
  
• Manage external microbial testing and relationships withexternal testing labs and suppliers.
  
• Develop the team in areas of technical expertise, use ofoperational excellence tools and high-performance team behaviours, includingstandard work, 5S and lean laboratory practices.
  
• Support laboratory equipment lifecycle, serviceprogrammes and new equipment introductions for the microbiology laboratory, andsupport method and equipment validation activities.
  
• Plan resource and capacity for the microbiology teamagainst the manufacturing schedule, and manage stock of media, consumables andreference cultures.
  
• Maintain the laboratory in an inspection-ready state andrepresent QC Microbiology during regulatory inspections, customer audits andinternal audits.
  
• Author, review and approve procedures, protocols,specifications, reports and change controls relating to microbiological testingand contamination control.
  
• Interface with other departments (Quality Assurance,Manufacturing, Facilities, Regulatory Affairs, Supply Chain) and with externalcontractors and contract laboratories as necessary.
  
• Participate as required in global project teams relatingto QC Microbiology, contamination control strategy and wider qualityactivities.
  
• Support budget preparation and monitoring, includingcapital equipment needs, facility needs, staffing needs and contract servicerequirements.
  
• Identify and conduct personnel training for microbiologystaff, prepare performance appraisals, and recruit and onboard team members.
  
• As required, act as designee for the Director, QC intheir absence.
  
• Other duties as assigned.
  

Required Experience & Skills

• Understanding and familiarity with FDA and Europeanregulatory requirements, guidelines and expectations for microbiologicalcontrol, environmental monitoring and aseptic processing.
  
• Previous experience of managing the performance ofindividual team members and of the overall team, including development andsuccession planning.
  
• Knowledge and experience of lean laboratory principlesand continuous improvement is preferable.
  
• Excellent written and verbal communication skills, with acustomer focus and ownership of the speed, quality and accuracy of delivery.
  
• Self-motivated, adaptable and able to work under pressurein a growing, multi-product environment.