Shire Manufacturing Operations Lead in Dunboyne, Ireland

This role will involve leading the Manufacturing days based, Operations team for 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 Shire, 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 overall responsibility for this role will be to lead the Manufacturing Operations Team, ensuring the plant operations on site are set up for success. This role is responsible for managing and tracking the site production schedule with key stakeholders, planning for product changeovers, audits, shift productivity monitoring and plant optimisations, ensuring that that all support activities are aligned to ensure production operations are run effectively and efficiently.

This is a critical role within the Manufacturing leadership organisation to help create value for our patients.

Responsibilities

SAFETY

  • Perform and drive the Manufacturing operations team to conduct track and measure safety audits, walkdowns and track, monitor and measure safety investigation progression with the shift leads.

  • 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 for plant audits and walkdowns.

  • Responsible for ensuring compliance with legal, EHS and all Shire policies and procedures which are applicable to the site.

  • Play a key role in the role out and management of safety initiatives in Manufacturing.

PEOPLE

  • Coach and mentor all employees on the manufacturing operations team including all indirect employees supporting the value stream and self-directed teams.

  • Support the creation of a high performing site organisation through implementation of a robust learning and development plan for the manufacturing operations 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.

FUNCTIONAL

  • Strategic Manufacturing Operations oversight and leadership at the Dunboyne Biologics start-up facility to meet functional and site goals and objectives.

  • Hire, develop, lead and coach your self-directed work team who will be key members of the self-directed work teams.

  • Drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.

  • Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, performance and budget management.

  • Responsible for ensuring the manufacturing facility is organised efficiently and that the shift teams are set up for success.

  • Lead on the tracking and managing of manufacturing issues or activities that require days support for closure.

  • Lead on the scheduling of all key site activities to ensure Dunboyne manufacturing operations run as effectively as possible to meet customer demands. Lead a team of schedulers to ensure that batch production, preventative maintenance, calibrations, validations and projects are all tracked appropriately within the site schedule.

  • Liaise with the shift manager team to ensure consistency and sharing of best practices across all shift teams. Attend and monitor consistency for the key tier 2 Value Stream meetings.

  • Lead a team of manufacturing specialists to focus on

  • Resource management in conjunction with the shift manager team in the areas of schedule attainment, holiday management and training

  • Development of plant optimisations working with the shift teams to progress initiatives in this area

  • Schedule tracking for the facility and management of shutdown preparations and changeovers between products

  • Development of suitable production focused metrics to track training, productivity, quality, EHS and supply chain targets

  • Manage non- process based deviations working in conjunction with the shift leads and the shift teams.

  • Drive the ongoing readiness of the site Emergency Response Team

  • Conduct plant walkdowns to ensure standards of GMP are being adhered to at all times

  • Coach and mentor the Manufacturing Operations team and the self-directed site teams.

  • Lead the self-directed team in meeting targeted site and Tech Ops objectives, ensuring department objectives are aligned, translated to all and visually managed to drive delivery.

  • 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.

  • Responsible for individual goal setting, ongoing performance reviews and development planning for direct reports.

  • Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on removing barriers to maintain a highly effective and productive self-directed team environment.

  • Responsible for ensuring compliance with legal, EHS and all Shire policies and procedures applicable to the site.

  • 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 the Shire Guide to Ethical Conduct.

Education and Experience Requirements

  • Bachelor’s degree in a technical discipline (Science or Engineering).

  • At least 8 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both).

  • Proven people manager and leader capable of developing people and teams with at least 5 years of management experience.

  • Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embrace an interdependent working culture.

  • Strong operations support background ensuring value added contribution and oversight.

  • Experience working in a GMP manufacturing environment, preferably liaising with or managing shift teams.

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: Leadership Behaviors

  • Be Positive

  • Be Accountable

  • 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.

  • Strong project management skills to support project delivery and operational readiness.

  • Strong stakeholder management skills to manage both internal and external stakeholders that support the site.

  • A proven ability to lead cross functional teams and deliver on tight timelines.

  • Excellent influencing/collaboration skills and teamwork mindset.

  • Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving.

  • Ability to challenge the status quo with a continuous improvement mindset.

  • Proven ability in using a wide variety of lean tools and building capability within teams.

  • 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.

  • Effective communicator with a proven ability to grow talent and future leaders.

  • Promoting a culture where diversity and inclusion is part of the DNA.

Complexity and Problem Solving

  • Establishes challenging assignments and stretch goals for self and team members and provides management 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.

  • Creating strategies and plans to manage risk within the engineering group.

Internal and External Contacts

  • Collaborate with Quality and EHS regarding investigations and changes controls impacting on manufacturing operations activities. Collaborate with Quality to foster a right first time culture in manufacturing to support quality excellence.

  • Collaborates with EHS but is accountable to drive a culture of everyone owns safety in manufacturing.

  • Collaborates with Facility Lead in relation to all facility change controls, facility improvements, facility investigations and scheduling facility activities that may impact on manufacturing.

  • Collaborates with QC, Warehouse and Supply Chain functions to ensure site schedule is up to date, active and being tracked to ensure site is functioning as a seamless business unit.

  • Collaborates with Plant Engineering and Maintenance for utility and plant support equipment in relation to scheduling shutdowns, plant maintenance works.

  • For delivery of the people strategy including recruitment, learning and development and organizational talent reviews collaborates with business excellence and HR but is accountable to develop a high performing technical organization in manufacturing.

  • Collaborates with all manufacturing members to deliver the site objectives

  • For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Shire and through external forums to drive business excellence in manufacturing.

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.