Job Type: Perm
Job ID: JO-2002-22125
Consultant: Karen McHugh
Do you have 4+ years of experience working in Microbiology in the pharmaceutical industry?
Do you have experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Microbiology Analyst- Cell Therapy - Dublin West - Dublin
Our client is one of the world's largest Pharmaceutical and Biotechnology companies and has multiple manufacturing sites across Ireland.
With major capital investment happening in their plants, this is an exciting time to join the team.
You will be responsible for oversight of the Microbiology laboratory supporting the manufacture of a Cell therapy product.
Oversee aseptic practices (gowning, monitoring, cleaning and related training).
Perform microbiological testing as required to support operations.
Perform environmental monitoring as required to support operations.
Ensure that the Microbiology laboratory is set up and operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global standards.
Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
Oversee the Cell Manufacturing Facility environmental monitoring programme for the facility.
Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
Manage an effective laboratory documentation system.
Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
3+ years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
Thorough knowledge of GMP and current FDA & EMEA regulations
Knowledge and experience of Lean Laboratories is preferable
Previous experience in setting up a new Microbiology laboratory is desirable
Strong Microbiology knowledge, with the ability to act as a Subject Matter Expert
€40 - 45K per annum, dependent on experience
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you are a Senior Microbiology Analyst interested in roles based in Dublin , you can contact Karen by e-mail email@example.com or phone +353-1-7978720 for a confidential chat.
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