mRNA Analytical Program Lead

To partner with PharmSci Analytical Research & Development, PGS Analytical testing sites and Global Technology & Engineering (GT&E) to ensure that robust, effective test methods for mRNA platform products are transitioned to PGS sites from ARD in a compliant manner to support declared plan of record for mRNA products. This position is also responsible for ensuring adequate capacity is maintained at the test sites 

Job Responsibilities: 

• Ensure analytical readiness of all PGS testing sites in line with agreed transition plan from Pharm Sci ARD 

• Partner with GCMC to ensure appropriate submission dates for new test sites. Submission dates should ensure capacity is added to the network as needed, while ensuring no impact to individual batch releases. 

• Manage overall PGS testing network capacity such that capacity constraints are predicted and mitigated prior to impact to release lead time 

• Facilitate the network stability forum – ensure all requests for stability studies are technically assessed prior to endorsement by QO leadership 

• Support the Biological Change Review Board (BCRB) to ensure efficient management of analytical changes through to approval 

• Partner with QC External support and Quality Assurance at the manufacturing sites to ensure National Control labs are efficiently onboarded and supported with any ongoing queries 

• Participate in mRNA Analytical sub teams to ensure support is applied to analytical technical issues which may impact release lead time 

• Partner with Pharm Sci ARD and GT&E to continuously improve method robustness 

• Lead the continuous critical assessment of PPQ sampling plans to ensure proposed testing is appropriate to the change being introduced 

• Lead efforts to continuously improve cycle time at PGS testing sites 

• Partner with External Supply Quality to expedite closure of any analytical investigations arising from product manufactured at a Pfizer CMO 

• In association with manufacturing site QO, ensure the Covid Vx testing network maintains continuous inspection readiness 

• Ensure capacity and resource planning at network sites takes account of proposed alternative vaccine presentations 

• Lead the analytical strategy for critical starting materials, applying reduced testing where appropriate 

Education / Experience 

• B.Sc. degree in biotechnology, biology, chemistry, or other related technical degree. 

• 10 years working experience in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment; with experience in a supervisory / management capacity 

• Experience leading matrix teams across complex projects 

• Previous QA /Compliance and/or Pharmaceutical experience in a GMP facility. 

• Excellent  proven written and verbal communication skills as well as proven experience in decision making. 

• Excellent interpersonal skills and be able to interact effectively with all levels of staff. 

• Ability to work independently as well as a member of a team in a dynamic, fast-paced environment 

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#LI-PFE