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Cell Culture Analyst

1 month ago

ireland PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 1-3 years
  • City Carlow
  • State/Province Carlow
  • Country Ireland
Job Description

About PSC Biotech

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 points, 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 to 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 through learning & development, in-house training, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the 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 support troubleshooting activities.
  • This is a day role, Mon-Friday based on site.

Requirements

Role 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, 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 assigned 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 documentation and ensure 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 a team of lab analysts.
  • Drive 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/readiness.
  • Work collaboratively to drive a safe and compliant culture.
  • May 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 cGMP.
  • Cell culture techniques, media preparation, cell thaw, and cell-based bioassays microscopy.
  • Laboratory Quality Systems.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Understanding of Lean Six Sigma Methodology preferred.
  • Effective communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
  • Planning and scheduling skills.
  • Flexible approach.
  • Proven organizational skills.
  • Effective time management and multi-tasking skills.
  • Excellent attention to detail.
  • 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 methodologies preferably in a GMP Setting.

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