Senior Microbiology Analyst- Cell Therapy - Dublin West - Dublin


Location: Ireland

Negotiable

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19279

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 karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.


Senior Microbiology Analyst- Cell Therapy - Dublin West - Dublin


Employer

​JobContax is a preferred supplier to one of the world's leading BioPharma companies. 

With major capital investment happening in their Irish plants, this is an exciting time to join the team


Job Description

Responsible for oversight of the Microbiology laboratory supporting the manufacture of Alofisel 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.

Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.

Training of microbiology analysts

Scheduling of microbiologist work via visual management

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 Therapy 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.

Oversight of contract testing laboratories associated with microbiological testing

Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.  

Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.

Manage an effective laboratory documentation system. Prepare and review documents as required.

Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).

Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.

Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.

As required, act as designee for the Plant Microbiologist in their absence.

Participate as required in global project teams relating to Microbiology and wider quality activities.

Participate fully in any cross functional training initiatives.

Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.

Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.

Ensure timely completion of all SOP, reading, training and assessment.


Requirements

More than 4 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

Excellent organizational, communication, interpersonal and report writing skills

Strong Microbiology knowledge, with the ability to act as a Subject Matter Expert

Ability to adapt to changing priorities


Package

Excellent benefits package

Performance Related Bonus

Health Insurance

Pension

Flexibility 

Paid Maternity/Paternity Leave

Educational Assistance Programme

Zero Absence Award

Talent & Development Programme

Occupational Health & Wellness Programme


Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720


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