QC Potency Analyst

1 month ago

Ireland CPL Healthcare Full time

QC Potency Analyst

Cpl in partnership with Pfizer are looking for QC Potency Analysts to join the team in Grange Castle site.

Pfizer Grange Castle, one of the largest integrated biopharmaceutical plants in the world, is producing supplies of the Covid-19 vaccine. Up to $40m will be invested in our manufacturing facility, which will lead to the creation of a diverse set of roles across our business. The Grange Castle facility will now produce the mRNA drug substance, making it only the second plant in our network to do so.

If you have relevant Quality Control Potency/Bioassay experience, this is a fantastic opportunity to join us on our journey to manufacture and test product breakthroughs that change patients' lives

The QC Potency/Cell Culture team are expanding and analysts joining our team will maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within the laboratory.

Job Responsibilities:

  • Execute testing for cell-based assays including Potency bioassays. In-Vitro Expression assays, In-Vitro relative antigenicity assays and ELISA.
  • Execute the following cell-based assays - Gene Expression, Apoptosis, Proliferation, In-Vitro Expression, Antibody-dependent cellular cytotoxicity, Complement-dependent Cytotoxicity.
  • Perform cell counting, cell seeding and cell passaging/maintenance.
  • Complete documentation associated with analytical results in a timely manner.
  • Facilitate and assist with laboratory investigations and corrective action tasks.
  • Peer review assay documentation and analytical results.
  • Ensure safe operations, attention to detail and good documentation skills according to cGMP.
  • Perform routine Potency & Cell Culture tasks including lab housekeeping.
  • Perform media preparation, critical reagent qualification and waste inactivation.
  • Assist in the maintenance and development of training programs and perform training of other analysts.
  • Maintain established 5S process and assist in the 5S audits and related activities.
  • Support and assist the continuous improvement projects and all related CI activities.
  • Follow and assist in the creation, review and maintenance of SOPs for cGMP lab test procedures and systems.
  • Contribute to the Quality Goals for the department and lab.

Education/Experience:

  • Minimum of 1 years' relevant experience necessary in a QC Potency position.
  • An ability to work independently, and as a member of a team in a dynamic, fast-paced environment that requires flexibility and initiative.
  • Excellent troubleshooting and problem-solving skills
  • Relevant Labware LIMS, SoftMax and Flow Cytometry experience desirable.
  • Strong organization skills, including ability to follow assignments through to completion.
  • Excellent communication and interpersonal skills.
  • Proven high level of attention to detail.
  • Shift work may be required for this role. Extended Days shift only.

Additional Detail:

  • To be considered for this position you need to be legally eligible to work in Ireland for the length of a permanent contract.
  • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
  • Due to high volume of applications, we will be contacting successful candidates only.
  • We do not offer relocation.
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