QC Potency/Cell Culture Analyst

Pfizer Grange Castle, one of the largest integrated bio pharmaceutical 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 QC (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. We are the EU testing site for the covid vaccine, and we celebrate our successes via recognitions and cake!

Together we will ensure that Science will win.

Job Responsibilities:

• Execute testing for cell-based assays including Potency bioassays and In-Vitro Expression assays and antibody-antigen 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.

• Support the creation of new LIMS (Laboratory Information Management System) builds for new Cell Lines and Assays.

• Support and assist in the introduction of New Products and Cell Lines.

• 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 2 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 trouble shooting 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.

What We Offer?

Permanent position with Competitive Salary and Shift Allowance plus Bonus Schemes, Healthcare for you & your family, Pension & Share Scheme, Long term Income Protection, Life Assurance, Option to buy Additional Annual Leave days. Grange Caste is close to the M50 and offers free parking and subsidized canteen onsite.
 

Additional Information 

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland. 

• Please note there is no relocation support available for this position 

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How to apply 

• Make a difference today, all suitable candidates should apply with CV below.  We are looking forward to hearing from you! 

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Purpose  

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. 

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. 

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. 

Quality Assurance and Control