Perform a technical expert role which will support the technology transfer of biologics drug products for the Cruiserath Sterile Drug Product facility.
Perform a technical expert role in various areas of aseptic manufacturing of parenteral dosage including equipment preparation, formulation, aseptic vial and syringe filling, and automated visual inspection.
Support parenteral technology transfer projects for key lifecycle biologic parenteral products, including the establishment of the process/parameters for each unit operation of the process.
Execute development studies, product characterisation studies, process optimisation and troubleshooting of manufacturing processes of parenteral dosage forms.
Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
Prepare and review technology transfer plans, development study protocols, validation protocols, technical reports, and operational procedures, as appropriate.
Prepare technical assessments on new materials and components. Prepare protocols and execute qualification of new materials and components.
Work cross functionally to lead any validation studies, process performance qualification and new product introductions in the SDP manufacturing facility.
Contribute to technical decision-making that impacts project deliverables and schedule for facility start up.
Develop and maintain effective working relationships with other division groups in support of technology transfer, validation, and process support activities.
Responsible to co-author and review key CMC section of regulatory filings.
Maintain compliance to industry standards and implement best practices across knowledge transfer, technology transfer, and process validation.
Qualifications
Experienced in parenteral operations including aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, and fill-finish operations.
Strong knowledge of global regulatory requirements, especially EU GMP guidelines and FDA CFR guidelines, related to the design and control of these processes.
Experienced with the execution of technology transfer and scale up projects for commercial drug product manufacturing processes.
Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
Proven ability to lead complex investigations relating to equipment, processes and systems associated with aseptic manufacture of drug products.
Experienced in sourcing and qualification of vial and/or syringe container closure and drug delivery systems.
Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture.
Excellent organisational skills, data science knowledge, and statistical skills are required.
Problem solving and project management ability, as well as lean manufacturing experience is desired.
