Dublin, County Dublin, Ireland
Experience in both upstream and downstream bioprocess manufacturing. My experience covers development and generation of SOP's and PBR's, deviation management, project planning, purification processing including affinity/cation/hydrophobic chromatography as well as other downstream manufacturing processes.
Manufacturing biologic's in a multi-product GMP facility, operating in all areas of purification. Operating large chromatography columns including: Protein A chromatography, Hydrophobic Interaction Chromatography, Anion Exchange Chromatography and Cation Exchange Chromatography. Purification of product through Depth Filtration, Virus Inactivation, Virus Filtration and concentration of product through ultrafiltration/defiltration. Working within the MES integration team. Consolidation of KPI data relating to manufacturing recipes and developing workflows required in the design and development of electronic batch records. Writing and reviewing of all downstream electronic batch records. Supporting multi-functional teams in the validation of new products and associated changeover. Creation of operating procedures & other relevant documentation for large scale manufacturing, including reviewing Standard Operating Procedures and Paper Batch Records. Participating in investigations and optimizations of processes using scientific, engineering and lean principles. Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (i.e. SAP. Trackwise, Maximo etc.). Assists with reviewing batch and exception reports. Engages in and supports culture of continuous improvement and operational excellence through ownership of improvement for work processes, equipment and safe work environment.
o Developing/updating documentation including SOP’s, Batch Records and Protocols for seed bioreactors during New Product Introduction (NPI) o Identifying key risk areas and implementing control procedures o Conducting investigations into process deviations, analysing and creating CAPA’s through Pfizer's QTS system. o Developing and implementing Continuous Improvement projects involving process change controls o Reviewing and updating BoM’s, reporting to other departments where issues arise. o Conducting Closure Risk Analysis on new products and processes coming into Drug Substance. o Review and Approve documentation for Up Stream and Media processes o Conduct investigations into Down Stream and Buffer process deviations, investigate potential for product impact, document and report on findings. o Support the introduction of new products into the current Drug Substance facility • PUP (Process Understanding Plan) Super User o Organisation of the process knowledge generated and captured during the commercial phases of a product including GMP and non-GMP documentation, Change Controls, Event, QARs, LIR’s, SOP’s, MBR’s, Protocols and Reports o Cross-functional management of teams to ensure information is collated and live documentation is accurate throughout the Product Lifecycle
Operational and Batch Readiness Coordinator/ Scheduler • Ensuring every stage of new product intregration runs effectively by coordinating interdepartmental communication identifying potential risks and tracking a resolve. • Develop recipes and schedules of activities involved with the implementation of trial and production batches into planning software - Orchestrate • Identification of key process variables and their interaction from a scheduling perspective to ensure process efficiency. • Assist in the mapping of processes both up and downstream in Visio. Process Technician/ NPI Operation • Experience working in a GMP environment. • Lead meetings to ensure SOPs/MBRs/PBRs are delivered on time. Liaise with different departments (Quality Assurance, Technicial Services, Systems Specialists, Team Leads, Engineering, Automation, Cleaning & Validation, Environmental Health and Safety). • Aid in maintaining updates on SOPs, batch records, and associated training packs, reviewing and progressing their path through PDOCS • Run reports on Good Save/Good Performance Saves for the Department and report on metrics. • Utilise MES and MCS to search for EBRs and ensure correct process flow is documented within associated documentation. • Developing a New Starter pack for all incoming trainees ensuring fast and effective integration into the workplace.
Liaise with both corporate and individuals regarding their training requirements, with this information build a development plan for their future. Establishing the necessity to offer courses with or without accreditation based on client needs. Tailoring training plans to include additional components. Relationship building is a key skill within this position as you need to trust the information you and getting from the client while more importantly the client needs to trust your training recommendations. This engineering of relationships extends beyond the account manager/client relationship to the trainer and those attending the training, as an account manager focus is not only on the contact but to whom the training is extended to. Asking the correct questions in a clear and concise manner while establishing clarity is vital. Developing a subtle but firm approach with relationships allows for the ease of debt collection, a skill in itself. Knowing when to escalate a potential debtor to senior management for loss prevention.
Managing a team of 11 part and full time employees, key skills involved recruitment, development and training of staff. Over seeing the running of major events for the location often involved coordinating staff between front of house, bar and restaurant. Cross training of staff was something I actively encouraged. Ensuring cash management for peak season events, conducting cash exchanges, lodgements and balancing tills. Basic stock management.
Training new staff, reservations management, overseeing the smooth running of the front desk. Coordinating group bookings, arrivals and check in/out. Communicating with third party reservation organisations, managing website availability. Forecasting occupancy rates and establishing comparisons to previous years. Assist in basic housekeeping, supervised corporate events. Creating travel plans for guests as well as recommendations for sites and restaurants based on individual preferences.