Plant Microbiologist

Competitive
Permanent
Dublin
08 Feb 2019
BBBH713571

A plant microbiologist is required to manage the Microbiology laboratory to support the aseptic manufacturing of a commercial Stem Cell product

A plant microbiologist is required to manage the Microbiology laboratory to support the aseptic manufacturing of a commercial Stem Cell product

RESPONSIBILITIES:

  • Responsible for the overall management of the Microbiology laboratory
  • Provide technical support for the qualification and validation of the manufacturing facility which includes Facility, Equipment, Environmental Monitoring program, Media Fills, Container Closure Integrity Validation, Process Validation and Continued Process Verification (process monitoring).
  • Establish and lead the Microbiology team supporting the technical transfer of Alofisel through to operation readiness: Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation.
  • Responsible for the Microbiology Laboratory Start-up activities which includes development of URSs, Risk Assessments, Protocols, Reports, SOPs, EOPs work instructions, procurement and qualification of equipment, software and utilities/facilities.
  • People manager responsible for recruiting, managing, training, development and performance reviews from project phase into sustaining production.
  • Responsible for the operation and inspection readiness of the Microbiology laboratory by ensuring the laboratory operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
  • Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
  • Manage the environmental monitoring to support the manufacturing of the Alofisel.
  • Lead and participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
  • Manage 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.
  • 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.
  • Generate, implement and control of Microbiology annual budget for consumables, capital and headcount.
  • As required, act as designee for the QC Bioprocessing Laboratory Manager in their absence.
  • Participate as required in global project teams relating to Microbiology and wider quality activities

EDUCATIONAL REQUIREMENTS:

  • Degree in Microbiology or other relevant field.

RELEVANT EXPERIENCE:

  • More than 7 years' experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
  • Extensive experience of microbiology testing including Contamination Control. Sterility, endotoxin, mycoplasma and Environmental Management
  • Thorough knowledge of GMP and current FDA & EMEA regulations
  • Previous experience managing the performance of individual team members and the overall team
  • Knowledge and experience of Lean Laboratories is preferable
  • Previous experience in start-up projects for aseptic filling facility including the associated Microbiology laboratory is desirable

SKILLS/COMPETENCIES:

  • Excellent organizational, communication, interpersonal and report writing skills
  • Strong Microbiology knowledge, with the ability to act as a Subject Matter Expert
  • Demonstrable experience managing, motivating and leading a team
  • Ability to adapt to changing priorities

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

Aoife Duggan's picture
Consultant | Science Recruitment
Cork, Limerick, Waterford +353 21 2300300 | aduggan@morganmckinley.ie