Operations lead for a new upstream and downstream biologics drug substance start up at Brinny. Leading operations team on facility, equipment and process design, install and qualification. Leading start up phase of programme covering equipment and facility PQ leading to Tech transfer and PPQ, attraction , recruitment and training programmes for newly formed integrated process team.

Responsible for provision of all Micro and Bioassay laboratory support to site, through a team of 35 analysts, supervisors and technical personnel.-Ensure delivery of all testing components required to supply high quality product through tactical planning and execution of laboratory schedules.-Provide on-going coaching and support to all team members, including the identification and development of key talent and skills within the team.-QC Labs Systems Integration, Technical Support and Engineering. Show less

Formation and management of a team of 10 technical personnel supporting all aspects of a Sterile Fill Finish area, C&Q, Process Validation, Process simulations etc.-Responsible for all technical and validation strategic decisions for the Sterile IPT, ensuring supply of all technical components required to deliver high quality product through tactical planning and execution of production schedules.-Responsible for annual requalification's of all Sterile facility systems, including autoclaves, depyrogenation equipment, HVAC, WFI, etc.-Development and control of requalification schedule, master validation plan and integration of same into production plan-Responsible for both annual and once off process simulation programmes in the Sterile area-Preparation and control of annual technical budget-Provided coaching and support to all team members, including the identification and development of key talent and skills within the team. Show less

Co-ordination and execution of all technical and validation activities within the time constraints associated with a Sterile manufacturing facility schedule.-Ensuring compliance with Safety and cGMP’s within group -Collaboration with engineering, manufacturing and quality teams to support the requirements of the operations area.-Collaboration with TS management team to support TS activities across the site.-Contract resource management to support project activities, ensuring that timelines were met and on budget. Show less

* Supported NPI into Sterile areas * Process Monitoring Support * Deviation and investigation support. * Continuous improvement champion in area.

Organisation, co-ordination and execution of validation studies within the time constraints associated with a manufacturing facility.-Experienced in Thermal mapping, Sterilisations, HVAC, Utility systems. Process Simulations etc.-Generation of validation documentation including, system validation plans, IQ, OQ, PQ, protocols/reports, requalification protocols/reports etc-Collaboration with engineering, manufacturing and quality teams in the execution of test plans and protocols for validation of cGMP systems, equipment and processes.-Training of new personnel Show less

* Testing of In-process samples from the Purification, Fermentation and Sterile Manufacturing areas. * Preparation and review of analytical results and batch documentation, under the time management constraints associated with In-Process testing. * Validation of new instrumentation and software, including IQ, OQ and PQ documentation. * Preparation of Protocols and Reports, and other GMP related documentation including, procedural updates and change notification.