* As part of the Technical Transfer team you will be responsible for the transfer of a syringe and/or vial commercial product from the client's existing lines to the newly expanded facility, as well as the transfer of a formulation process from a US site to Co. Carlow site.
* As part of your role you will be working with a cross functional team to ensure that all aspects of the technical transfer process will be adhered to and you will be expected to collaborate with multiple internal and external departments.
* The role will include early engagement with the construction team to ensure that process requirements are embedded into equipment and facility design and construction while helping to build and execute the technical transfer plan for the product.
* Process development studies and engineering batches will lead up to the goal of completing the Product and Process Qualification batches in 2022.
Core Duties and Responsibilities:
* Within this role you will be working within the technical transfer team, reporting to the Technical Transfer Lead. As a member of the team you will:
* Execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: engineering studies, equipment tuning, development batches, single use component fit checks, process simulations, PPQ's, etc.
* Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met.
* Provide technical and product guidance to the process, design and project delivery teams.
* Author and review procedures and technical reports as required as part of the technical transfer.
* Review and approve Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
* Lead and support component criticality assessments for the process and create control strategies.
* Execute activities as part of the Change Management process for the product introduction.
* Apply LeanSixSigma and Change Management tools to identify process improvements.
* Represent the site in internal collaborations with Technical Transfer and Commercialization teams to include sharing of best practices.
* Keep up to date with scientific and technical developments, best practices and attend seminars as required.
* Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
Minimum Qualifications and Experience:
* This role requires an experienced individual with a minimum of 2 years directly related experience in academia, pharmaceutical or biotechnology industry - along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
* The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
* S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
* Preferred Experience and Skills:
* Process or technical transfer experience.
* Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines
* Experience with liaising with other departments - engineering, technical, operations, supply chain, QA and Regulatory Affairs.
* Experience with sterile processing and sterilisation technologies
* Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
* Desirable but not essential:
* Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus
* Familiarity with 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
* Vial / Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
* New facility brown/ green field facility experience, as well as experience in process development and experiment design.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
(phone number removed)
Click here to submit your CV
Please note, we do not require agency assistance with this role