This person will be responsible for the transfer of a syringe product to the client site. As part of your role you will be leading a technical team to ensure that all aspects of the technical transfer process are adhered to.
· Lead and execute process engineering activities to support the technical transfer of products to the site. This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning, PCM, CTU mapping, filter validation, etc.
· Plan, schedule and resource the complete technical transfer programme and then to lead the team to successful completion of the product introduction to regulatory approval and initiation of commercial production.
· Providing technical and product oversight to the process, design and project delivery teams and coaching to associate staff within the assigned suite.
· Author and review procedures and technical reports required as part of the technical transfer.
· Technical review and approval of Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
· Owning Change Management process for the product introduction.
· Effective application of LeanSixSigma and Change Management tools
· Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
· Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices.
· Minimum of 10 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
· Demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
· Leadership experience managing a team to deliver short and long term objectives as part of a project or program.
· Project Management experience / training in use of Project Management tools.
· SME on Equipment within a sterile fill finish environment; e.g. CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels
· Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.