Cpl, in partnership with our client Pfizer, are currently recruiting for a Process Scientist to work in their state of the art biopharmaceutical manufacturing facility in Grange Castle, Dublin West.
Provide process science and validation support to the Parenterals syringe filling and adjuvant production operations, as well to support process tech transfer projects into site for any new products/processes that may arise. The process scientist is responsible to ensure that the process is running as intended, that it is appropriately validated and run so as to maintain that validated state.
The successful candidate will work within the technical services team and establish strong network partnerships (MSAT, Pharm Sci and Co-Dev) to deliver integrated technology solutions to enable the site business objectives. The role may entail specialisation and training in process science/engineering to meet overall site business needs for technical support e.g. Process validation, technical risk evaluation, filtration, disposables, drug product formulation, colloid formulation, Aluminium phosphate manufacturing, syringe filling and inspection etc. In addition the role may involve travel to external donor sites to capture process knowledge.
- Coordinate the Continuous Process Verification (CPV) program in Suite 3 to ensure the manufacturing processes remain in a validated state. This involves both a proactive and reactive approach to trends observed in both drug substance and drug product manufacture both in Grange Castle and across the Pfizer network.
- Provide in-depth process expertise to support the manufacture of sterile vaccine and adjuvant products - process change, troubleshooting and resolution of manufacturing process and technology issues.
- Write product/process impact assessments in support of investigation closures.
- Work to implement a culture of Right-First Time through partnerships with Operations and other functions on-site and provide leadership in the use of OE principles to optimise our technical and business processes.
- Carry-out process transfers to site in-line with existing guidelines, network procedures and with industry best practices.
- Participate or lead technology transfers of new processes or equipment. Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating site personnel.
- Participate in Gap Analyses and Risk Assessments to support the Tech transfers.
- Author Technology Transfer Documents.
- Liaise with other site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to or from Grange Castle.
- Complete facility fit assessments in support of process transfers and facility design.
- Develop and maintain mass balances and process flow diagrams (PFDs) for new processes.
- Assist in the development of the Bill of Materials (BOM) and Sampling Plan for new processes.
- Collate relevant key tech transfer documents specified in the tech transfer plan.
- Support the introduction of new materials and review Supplier Change Notifications (SCN) as required
- Support the execution of engineering trials, demonstration batches and process validation batches
- Develop process validation protocols and lead their execution on the floor in conjunction with Operations. Write up process validation summary reports and associated filing summaries.
- Develop cleaning cycles for new process and equipment. Develop cleaning validation protocols and coordinate their execution with Operations and Engineering. Write up the cleaning validation summary reports.
- Carry out process monitoring of commercial processes and work to improve process capability where weaknesses are identified. This includes development of new technology solutions where applicable
- Design and execute Filter Validation, Media simulation and Shipping Validation studies.
- Provide subject matter expertise for significant events, regulatory submissions and audit response.
- Assess the use of new technologies, including disposable technology and the potential impact of adverse Leachables and Extractables profiles.
- Lead or Manage change controls for Technical Services, and track all Actions items to closure.
- Liaise with cross-functional expertise to resolve manufacturing process and technology issues.
- Provide technical training on process and technology areas as required by the Project.
- Support the authoring of Annual Product Quality Review (APQR).
- Lead major process investigations, perform root cause analysis and support the implementation of CAPAs.
- Minimum of 2 years industrial experience in technical, quality or operations role at an aseptic GMP manufacturing facility.
- Strong statistical background with experience working with Minitab, Informa and APQR.
- Experience working with statistical trends across manufacturing, release or stability.
- Demonstrate an aptitude for technical learning and problem solving.
- Experience and knowledge of drug product formulation and/or media simulations and/or aseptic filing and/or their inspection technologies preferred.
- Experience and knowledge of process and cleaning validation will be an advantage.
- Knowledge of Quality requirements and Regulatory guidelines.
Minimum qualification of a B.Sc. Degree in Bioprocess Science, Engineering, Biotechnology or equivalent with a preference for Biochemical, Chemical or Biological disciplines.