Job Description

This role will involve being a member of the manufacturing team in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Takeda, the leading global biotech company focused on rare diseases. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
The Manufacturing BioTech Associate will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to achieve the strategic objectives related to Safety, Quality/Compliance, Supply Assurance (i.e. capacity, yield, fulfilment), and Value.
The Manufacturing BioTech Associate will undertake manufacturing operations involved in the production of biologic drug substance on their designated shift. Key responsibilities include the progression of an automated recipe using paperless technology in order to generate the drug substance through inoculation and cell culturing activities leading to filtration and purification of the product in a state of the art single-use technology-based facility. The incumbent will be involved in setting up the single-use equipment between runs, carrying out the production process according to world-class GMP and EHS principles and driving to optimise and improve the processing activities through the use of standard work and lean processing techniques. At all times this role is focused on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and a concentrating on the engagement and development of self and peers.
Responsibilities
SAFETY
+ Partner with the EHS Hub to ensure sustainable EHS programmes are engrained and deployed, to develop effective integrated solutions to EHS requirements, to develop a valuable EHS learning programme for you and to assist with safety initiatives.
+ Stay actively involved by participating in inspections, GEMBAs and Go-See’s, reporting safety observations.
+ Challenge and identify improvements to the safety and environmental programmes on site.
+ Be a visible leader of safety initiatives and stay actively involved in safety forums.
+ Take part in safety audits, walk downs and report on, and look to resolve any unsafe activities or situations that occur during manufacturing activities, taking ownership as required as part of the site culture on safety
PEOPLE
+ Celebrate with the use of proactive recognition tools that inspire teams and individuals.
+ Create an environment where everyone speaks up for our culture of safety and looks out for one another.
+ Be an ambassador for the Takeda leadership behaviours of accountability, be positive, results driven and excellent manager of self and others.
+ Ensure that all employees on shift supporting manufacturing are working as one team to support the delivery of product to patients.
+ Be responsible for the shift skills matrix to drive a learning and development organisation as well as maximising flexibility across the shift team
+ Act as a coach or mentor to one’s peers on specific unit operations as required to support the value stream
+ Play an active role in the shift handover process, working to ensure that transitions occur as smoothly as possible and that the production activities are closely monitored and controlled always.
+ Role model the behaviours that creates a culture of respect and dignity in line with Takeda Guide to ethical conduct
DELIVERY
+ Utilize continuous improvement tools, lean and six sigma methodologies to identify improvement opportunities perform technical troubleshooting and successfully implement solutions.
+ Support the implementation of site strategy and business unit strategy by identifying appropriate initiatives for applicable improvements to the value stream. In some instances, support corporate initiatives and projects.
+ Identify the appropriate business drivers for each initiative, draft proposals and seek appropriate governance approvals as required.
+ Prepare timely project reports and communicate effectively with all stakeholders including reporting any potential project delays timely and provide mitigation plans to assure on-time execution.
+ Reporting of Value Stream Key Performance Indicators & Metrics.
+ Support the implementation of the Lean Management System.
+ Undertake job-specific activities
+ Drive the production process forward through use of Delta V recipes & MES Electronic Batch records according to relevant SOPs
+ Take ownership for one’s own training to continue professional development and generate expertise in the role
+ Play a key role in the rollout and development of standard work processes on the plant, continually looking fo
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