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 PropositionEmployees 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. Overview:Responsible for the effectiveness of the Cell Culture
laboratory focused on carrying out cell culture techniques, culture
handling-maintenance and culturing of cell lines and carrying out cell-based
bioassays.Act as a cell culture SME and supporting troubleshooting
activities.This is a day role, Mon-Friday based on site.RequirementsRole Functions:Work as directed by the Quality Control Manager /
Associate Director, according to Company safety policies, cGMP and cGLP.
Required to drive compliance with client’s Global policies, procedures and
guidelines and regulatory requirements and execute Good Manufacturing Practices
(cGMP) in the performance of day to day activities and all applicable job
functions.Perform routine cell culture maintenanceResponsible for planning and overseeing cell culture activitiesDevelop, implement and maintain procedures that comply
with appropriate regulatory requirements.Ensure that all Quality Systems within the department are
adhered to on a daily basis.Operate as part of the QC team performing the allocated
testing and laboratory based duties.Participate in laboratory management (equipment, stocks,
cleaning)Ensure timely completion of all assigned data processing
and reviewing.Ensure timely completion of Laboratory Investigation
Reports and deviations through site procedureParticipate in QC Tier 1 daily meetings and ensure
effective communication of testing progress, deviations etc.Peer review testing documentation and ensuring data
integrity compliance and QC Right First Time KPIs are achieved.Where applicable, review, approve and trend test results.Participate in the laboratory aspects of OOS investigationsAbility to lead/mentor team of lab analystsDrive continuous improvement, perform root cause analysis
on system failures and substandard equipment performance, using standard tools
and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams,
5 why's etc, Provide support with audit/inspection requirements to
ensure department compliance/readinessWork collaboratively to drive a safe and compliant
cultureMay be required to perform other duties as assigned Experience, Knowledge & Skills:Knowledge of regulatory/ code requirements to Irish,
European and International Codes, Standards and Practices.Knowledge of cGMPCell culture techniques, media preparation, cell thaw and
cell based bioassays microscopyLaboratory Quality SystemsProficiency in Microsoft Office and job-related computer
applications requiredReport, standards, policy writing skills requiredUnderstanding of Lean Six Sigma Methodology preferred.
4.2 Business:Effective communication, presentation and interpersonal
skills, to interface effectively with all levels of colleagues and with
external customers in a team orientated manner.Planning and scheduling skillsFlexible approachProven organizational skillsEffective time management and multi-tasking skillsExcellent attention to detailTrouble shooting skillsExperience in handling adherent and suspension cell lines Qualifications & Education:Minimum Education: Bachelor’s Degree or higher preferred;
ideally in a science related discipline.Typical Minimum Experience:2 years prior related work in handling cell culture and
cell culture methodologies preferably in a GMP Setting.