QC Microbiology Manager

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

• The QC Microbiology Manager reports to the Head of QC and is responsible for leading the QC Microbiology laboratory team . The team delivers the microbiological testing that underpins release and monitoring of drug substance and drug product, including anaerobic bioburden, environmental monitoring, water sampling, plate reading, growth promotion and associated trending and reporting.
  
• It is expected that the incumbent will lead in a high-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 strong organisational and planning skills.
  
• The incumbent must possess technical expertise in microbiology and aseptic operations, and demonstrate both technical and personnel leadership. The role provides co-ordination and alignment between QC, QA, Manufacturing, Facilities and Supply Chain so that microbiological testing and monitoring commitments are delivered in line with the site supply plan and quality capacity.
  
  

Requirements

Key Responsibilities

• Lead the QC Microbiology team to operate in compliance with current cGMP standards at all times, ensuring samples are tested and results delivered within specified timelines.
  
• Own the site environmental monitoring and utilities (water and compressed gases) monitoring programmes, including routine execution, periodic review, quarterly reporting and trending.
  
• Provide oversight of out-of-specification, out-of-trend and excursion investigations, including microbial identification, root cause analysis and documentation of corrective actions.
  
• Own and provide oversight for sterility testing program on site related to the Drug Product Facility onsite.
  
• Manage external microbial testing and relationships with external testing labs and suppliers.
  
• Develop the team in areas of technical expertise, use of operational excellence tools and high-performance team behaviours, including standard work, 5S and lean laboratory practices.
  
• Support laboratory equipment lifecycle, service programmes and new equipment introductions for the microbiology laboratory, and support method and equipment validation activities.
  
• Plan resource and capacity for the microbiology team against the manufacturing schedule, and manage stock of media, consumables and reference cultures.
  
• Maintain the laboratory in an inspection-ready state and represent QC Microbiology during regulatory inspections, customer audits and internal audits.
  
• Author, review and approve procedures, protocols, specifications, reports and change controls relating to microbiological testing and contamination control.
  
• Interface with other departments (Quality Assurance, Manufacturing, Facilities, Regulatory Affairs, Supply Chain) and with external contractors and contract laboratories as necessary.
  
• Participate as required in global project teams relating to QC Microbiology, contamination control strategy and wider quality activities.
  
• Support budget preparation and monitoring, including capital equipment needs, facility needs, staffing needs and contract service requirements.
  
• Identify and conduct personnel training for microbiology staff, prepare performance appraisals, and recruit and onboard team members.
  
• As required, act as designee for the Director, QC in their absence.
  
• Other duties as assigned.
  

Required Experience & Skills

• Understanding and familiarity with FDA and European regulatory requirements, guidelines and expectations for microbiological control, environmental monitoring and aseptic processing.
  
• Previous experience of managing the performance of individual team members and of the overall team, including development and succession planning.
  
• Knowledge and experience of lean laboratory principles and continuous improvement is preferable.
  
• Excellent written and verbal communication skills, with a customer focus and ownership of the speed, quality and accuracy of delivery.
  
• Self-motivated, adaptable and able to work under pressure in a growing, multi-product environment.