Cell Culture yst
Cell Culture yst
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Job Description
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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 handlingmaintenance and culturing of cell lines and carrying out cellbased bioays.
- Act as a cell culture SME and supporting troubleing activities.
- This is a day role MonFriday based on site.
Requirements
Role Functions:
- Work as directed by the Quality Control Manager / ociate 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 maintenance
- Responsible for planning and overseeing cell culture activities
- Develop 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 igned data processing and reviewing.
- Ensure timely completion of Laboratory Investigation Reports and deviations through site procedure
- Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress deviations etc.
- Peer review testing doentation 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 investigations
- Ability to lead/mentor team of lab ysts
- Drive continuous improvement perform root cause ysis on system failures and substandard equipment performance using standard tools and ods to resolve machine and system issues e.g. FMEA Fishbone diagrams 5 whys etc
- Provide support with audit/inspection requirements to ensure department compliance/readiness
- Work collaboratively to drive a safe and compliant culture
- May be required to perform other duties as igned
Experience Knowledge & Ss:
- Knowledge of regulatory/ code requirements to Irish European and International Codes Standards and Practices.
- Knowledge of cGMP
- Cell culture techniques media preparation cell thaw and cell based bioays microscopy
- Laboratory Quality Systems
- Proficiency in Microsoft Office and jobrelated computer applications required
- Report standards policy writing ss required
- Understanding of Lean Six Sigma odology preferred. 4.2 Business:
- Effective communication presentation and interpersonal ss to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
- Planning and scheduling ss
- Flexible approach
- Proven organizational ss
- Effective time management and multitasking ss
- Excellent attention to detail
- Trouble ing ss
- Experience 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 odologies preferably in a GMP Setting.
Knowledge of cGMP Cell culture techniques, media preparation, cell thaw and cell based bioays microscopy Laboratory Quality Systems Proficiency in Microsoft Office and job-related computer applications required Report, standards, policy writing ss required Understanding of Lean Six Sigma odology preferred. 4.2 Business: Effective communication, presentation and interpersonal ss, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Planning and scheduling ss Flexible approach Proven organizational ss Effective time management and multi-tasking ss Excellent attention to detail
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 odologies preferably in a GMP Setting.
Employment Type
Full Time
