Technical Lead
Hartley People
Waterford
Description. Our client, based in Waterford currently have a vacancy for a Development Scientist Technical Lead . This is an opportunity to join a global company in a challenging and rewarding role with excellent opportunities for personal development. Purpose of Role. The purpose of the role is to contribute in a pivotal strategic role in the transfer of leading pipeline products from Research & Development into commercialisation and launch as well as transferring in successful commercial products. The Role. Process Development and Technical Transfer processes for clinical products from R&D to commercial manufacturing, for established commercial products Line to Line transfers and form new process & technology improvements. Applies to all process transfer technical deliverables from knowledge capture, to on- the-plant implementation, through to validation to regulatory CMC submission and approval. Develops the Technical Development and Technology Transfer Plans and ensure right first time delivery to meet the technical acceptance criteria. Provides Process Transfer Technical Leadership on the cross-functional Tech Transfer/NPI project team & at Technology Development and Transfer Governance Forums. Provide in-depth expertise on Technology Transfer systems, methods and procedures to the Technical Development NIP team and ensures compliance with Policies and Procedures for Technical Transfers. Provides the Technical expertise to drive the key Technology Transfer Technical Decisions. Authors the Technical Development Technology Transfer Plans and ensures execution through the Tech Transfer gates. Tech Transfer execution, deviation resolution and validation reports are done in collaboration with the joint Tech Transfer process teams. Compiles Technology Transfer Summary Report to support approval through the Tech Transfer gates. The Person. A Bachelor’s Degree in Science, Engineering or equivalent; ideally have attained further qualifications e.g. M.Sc. 7- 10 years in biopharma/pharma industry essential with technical expertise in a range of products and their associated manufacturing sciences, process & analytical technologies. Technical or program leadership experience of technical transfers. A proven track record in the ability to transfer goals and objectives into measurable plans and right first time delivery. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent. For immediate consideration please call Audrey on 051-878813 or email your CV in a word document to audrey @hartleypeople.com.
3288 days ago