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Shire Site Shift Lead in Dunboyne, Ireland
Site Shift Lead - Dunboyne
The Site Shift Lead will lead all manufacturing operations as well as support activities on their designated shift for our new state of the art single use multi-product biotech facility in County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. Key responsibility includes leading a team of manufacturing, maintenance, automation and quality professionals who are responsible for the day to day shift operations at the site. This role will ensure that all aspects of the Dunboyne culture including commitment to safety, right first time in everything we do and a focus on the engagement and development of employees is prioritised. This role is a critical role on the manufacturing leadership team as well as the most senior person on shift at the site.
Member of the site emergency response team, act as site Incident Commander in the event of an accident or incident on site.
Perform safety audits, walk downs and leads on safety investigations on shift – report and resolve any unsafe operations.
Build safety as a value within every aspect of the value stream supporting manufacturing operations that ensure sustainable EHS programmes that are engrained and deployed into each area.
Liaise with statutory agencies as required – and acts as primary site contact with agencies in the off hours.
Responsible for ensuring compliance with legal, EHS and all Shire policies and procedures which are applicable to the site.
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.
Coach and mentor all employees on shift including all indirect employees supporting the value stream.
Support the creation of a high performing site organisation through implementation of a robust learning and development plan for the shift team, providing feedback to all employees on shift and the implementation of a robust communication plan to the shift including 1:1s, skip levels, development planning, and regular site updates.
Celebrate with use of proactive recognition tools that inspire teams and individuals.
Create an environment where everyone speaks up for 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.
Role model the behaviours that creates a culture of respect and dignity in line with Shire guide to ethical conduct.
Responsible for the goal setting, ongoing performance reviews and development planning of each employee on shift.
Lead the site shift operations ensuring that all manufacturing operations are completed to schedule. This includes completion of batch record review, investigations and the completion of all scheduled activities including sampling, cleaning, preventative maintenance, calibration, changeovers, validations and projects.
Provide timely visibility through tier meetings and visual management on progress against value stream KPIs, delays, action plans, improvement opportunities and recognition.
In partnership with the manufacturing leadership team create and sustain a culture of excellence in safety, quality and continuous improvement.
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 as part of the tier meeting structure and ensure shift automation and process engineering are engaged in making changes/ improvements that support right first time improvement and error proofing.
Be accountable for a robust investigation process to drive to right first time.
Ensure objectives are aligned, integrated across the shift team, translated to all and visually managed to drive delivery.
Deliver on the annual business plan including all KPIs related to safety, quality, people and productivity in partnership with the site manufacturing leadership team and the value stream leadership team.
Represent Dunboyne Plant internally and externally to promote Shire Dunboyne as a great place to work and to support delivery of benchmark site performance.
Responsible for ensuring compliance to all requirements of current Good Manufacturing Practice.
Strengthening overall leadership and organizational capabilities in area of responsibility.
Be ready and capable of leading on discussions with auditors on plant based activities and in leading on audit walk downs.
Play a key role in delivering the start-up plan for the site, acting as an area SME during the handover process from commissioning through into qualification and process validation.
Education and Experience Requirements
Bachelor of Science or Engineering degree or equivalent.
A minimum of 8+ years’ experience in Bio-Pharmaceutical Manufacturing / Engineering with 3+ years’ experience required in a leadership role with a multi-national organisation. This experience must include biologics drug substance, with start-up experience being a distinct advantage.
Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.
Experience working in an automated facility would be a distinct advantage
Key Skills, Abilities, and Competencies
Ability to translate the vision and goals of the company and site to the shift team.
Enterprise mind-set to ensure the right prioritisation for the manufacturing operations.
Strong planning and project management skills to support delivering the integrated manufacturing schedule.
Strong stakeholder management skills to manage stakeholders across the various function’s that support manufacturing.
A proven ability to lead a team of highly engaged employees.
Excellent influencing/collaboration skills and teamwork mind-set.
Excellent trouble shooting and problem solving skills as well as ability to coach and mentor teams through complex problems.
Ability to challenge the status quo with a continuous improvement mind set.
Proven ability to using a wide variety of lean tools and building capability in teams you have led that becomes the standard way work gets completed.
Change agent who will support the organisation with good change management tools and techniques.
Strong Talent Developer with a focus on creating a continuous learning organisation through active coaching.
Proven ability to grow talent.
Promoting a culture where diversity and inclusion is supported.
Ability to drive implementation of lean automated process through standard work, tier meetings, visual management and problem solving.
Complexity and Problem Solving
Identifying and communicating risks in delivery of the manufacturing schedule.
Creating action plans to manage risk to the operations.
Internal and External Contacts
For Quality Organisation partner with QA Operations Support to ensure that all GMP activities that support manufacturing of product at Dunboyne are done in a consistent, compliant and a timely manner.
Provide support to QA on shift through a robust communication plan and ensuring they are integrated as part of the shift team.
For Manufacturing, Science & Technology (MS&T) collaborate to ensure the required technical support is available to the shift team during complex events including validation runs, implementation of new technology or major investigations.
Collaborate with Manufacturing HR Business Partner to ensure recruitment, learning and development of all employees on shift is prioritised.
Collaborate with other members of the manufacturing leadership team to ensure that all activities that are required to support an efficient and effective manufacturing schedule are delivered including master manufacturing recipe, change control, investigation management, projects, and master production schedule.
For Maintenance support the shift maintenance team to ensure preventative maintenance and calibration schedules are maintained and provides support in terms of shift priorities.
For Automation support the shift automation engineer in terms of priorities for actions that support closeout of action items and process improvements.
For Supply Chain collaborate to ensure all processes and systems supporting planning, purchasing and warehousing, distribution are developed and tracked to support PAI readiness and commercial manufacture.
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.