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Shire Senior Manufacturing BioTech Associate in Dunboyne, Ireland
The senior 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, fulfillment), and Value.
The senior manufacturing biotech associate will undertake manufacturing operations involved in the production of biologic drug substance on their designated shift and act as a coach and a technical point of contact for others on the shift team, acting as a key liaison for the site shift lead for ongoing operations in a process area. 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 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.
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
Celebrate with 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 Shire 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 Shire Guide to ethical conduct
Utilize continuous improvement tools, lean and six sigma methodologies 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.
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 roll out and development of standard work processes on the plant, continually looking for improvements and operational efficiencies
Always conduct work activities in a safe and compliant manner
Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions
Act as a team member on process deviation reviews and Gemba walk downs
Act as end user where required for manufacturing input into automation, equipment and process changes to ensure that the operational aspects of any change are well understand and effective.
Mentor new members of staff in specific plant activities
Assist in project activities as they arise to maintain and optimize the facility
Play a key role in streamlined changeovers between products and in between batches
Be prepared to answer auditor questions during site walk downs.
Encourage new and innovative approaches to improve the value stream.
Engage in implementing innovative solutions that drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
Education and Experience Requirements
A degree or equivalent in a technical, engineering or science based discipline
Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required
A proven ability to work as part of a team to deliver results
Organization Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
Key Skills, Abilities, and Competencies
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be an Excellent Manager of Self and Others
Ability to translate the vision and goals of the company and site to the Self-directed teams.
Enterprise mindset to ensure the right prioritisation for the site.
A proven ability to play an active role in cross functional teams and deliver on tight timelines.
Ability to challenge the status quo with a continuous improvement mind-set.
Promoting a culture where diversity and inclusion is part of the DNA.
Complexity and Problem Solving
Establishes challenging assignments and stretch goals for self
Provides support and guidance to team members on prioritization and resource allocation to achieve goals in accordance with established polices and business needs.
Identifying and communicating risks in area of responsibility and across the site.
Internal and External Contacts
Collaborates with the Technical Operations Training Community and Continuous Improvement teams across the Organisation.
Collaborates across the Self-Directed Work Teams and Hubs to coach, mentor and develop the lean and six-sigma capability within the teams to develop their skill-set
For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Shire and through external forums to drive business excellence.
Works closely with the Maintenance, QA and EHS departments to deliver product safely, in a compliant manner on time
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.