Technical Transfer Lead – REF 01934MQ

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. 

Main Responsibilities:

·           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.

 

Requirements:

·           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.

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