Operations Director
Location: Swords, Co. Dublin, Ireland
ABOUT US?
SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver life-changing therapies that improve patient outcomes and save lives’. The facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at www.skpharmteco.com
Current need:
A vacancy now exists for the Operations Director position within SM Europe. This is a senior position, incorporating head of function and membership of the leadership team. The Director of Operations has responsibility for all 24/7 operational activities relating to the Manufacturing plants on the Swords Small Molecule site including the processes, people, equipment, and systems. They are also responsible for support functions i.e. maintenance, sustainability and environmental services (technical services), AIM, process engineering and warehouse. The Director is required to provide effective leadership to this group to ensure Swords is a Customer focused organisation supporting the site’s delivery KPI’s, and achieving safe, high-quality product. This role is expected to contribute significantly to the development and implementation of strategy and to the effective performance of the site. This role plays a key role in ensuring uninterrupted manufacturing of intermediates and API.
Key aspects of that role are set out below.
This role through the shift manager structure has responsibility for all operations and support functions ‘outside of day hours. The Operations Director role is based on-site at Swords, reporting into the President of Small Molecule Europe.
More specific responsibilities will include the following:
1. To ensure continuity of supply and a stable and productive work environment.
2. To develop capabilities required to support successful implementation of the SM Strategy.
3. To drive the end-to-end delivery of product.
4. To drive effective interfaces with other functions and draw in appropriate resources to ensure that strategic and operational objectives are achieved.
5. To ensure that Operations team achieve the required product throughput on time, to Quality and SH&E compliance standards and within cost targets.
6. To provide technical leadership in achieving process and capacity improvements.
7. To develop and implement strategies in the department that support the manufacturing of commercial and clinical products.
8. To ensure the effective management of all operations on a 24/7 basis.
9. To effectively manage financial budgets.
10. To support Opex initiatives and sponsor black, green belt projects.
Manage Organisation Structure:
1. To develop and promote engagement initiatives within operations that will promote and achieve a positive culture.
2. To monitor and review the department structure ensuring that it is the appropriate vehicle for delivery of key objectives and key performance indicators required from this area.
3. To ensure that the structure can deliver on key performance indicators and objectives.
4. To ensure that associated functions provide the required support so that key objectives and outcomes are achieved.
Manage Operations:
1. Working through your leadership team and by influencing support functions: Ensure that production targets are met in a consistent and timely manner with particular focus on throughput, yield, quality, labour utilisation and expense control.
2. Ensures procedures are in place so that production plants, warehouse, technical services and utilities are operated and maintained in a manner which meets all Safety, cGMP, Quality and Environmental Standards.
3. Plans effectively for the future and implements strategies in relation to process improvement and removing bottlenecks to maximise plant efficiency.
4. Reviews and approves production schedules.
5. Responsible for yield and quality on scale-up, equipment selection, waste minimisation and process safety evaluation.
6. Perform capacity analysis studies as appropriate to ensure Swords are well positioned to meet customer demands.
7. Identify and implement plant system modifications (process, automation, equipment and documentation) to improve productivity (yield/through-put), safety, quality and customer service.
8. Ensure effective predictive and preventative maintenance programmes are adhered to.
9. Ensure ‘best in class’ plant containment procedures are adhered to and containment best practices are employed.
10. Work with supporting functions to introduce new products on time and to continue to improve the performance of the delivery process.
11. Work in conjunction with OPEX site lead to drive continuous improvement within operations.
12. Manage communications across departments and across organizational boundaries.
cGMP and SH&E Responsibilities:
1. In order to maintain and continuously improve our compliance levels, it is the responsibility of the position to monitor GMP and SH&E compliance through shop floor presence and to take appropriate corrective action where needed.
2. Responsibility for ensuring plant readiness for customer visits, regulatory inspections and audits.
3. Training of all personnel must be done with most compliant, effective assessment-based system.
4. Ensure documentation is completed correctly first time and monitor to ensure that indicative metric is achieved.
5. Ensure that all quality and SH&E metrics are achieved.
6. Contribute to regulatory submissions associated with plant.
Key requirements for this role include:
1. Excellent communication and inter-personal skills. Ability to work in cross functional, multicultural teams. Core competencies of Leadership, Communication skills, Teamwork, Problem Solving, SK Behaviours and a Commitment to Compliance and Continuous Improvement.
2. A thorough understanding of plant operations and engineering projects is essential.
3. A knowledge of regulatory & safety guidelines is necessary. An ability to contribute strategically at leadership level is a requirement as well as effective networking and stakeholder management skills.
4. Ability to motivate and engage your team and in so doing to develop a positive culture.
5. The ability to contribute positively to the site leadership team, in that context acting in support of what is best for the site, not just functional objectives.
Qualifications requirements:
1. Minimum of an Honours degree in a science or engineering related subject.
2. In-depth knowledge of relevant cGMP, safety and environmental regulations.
3. Minimum of 10 years technical experience in a bulk pharmaceutical manufacturing facility.
4. Significant Management experience essential.
5. Management experience in a function related to manufacturing would be an advantage.
6. A business qualification in addition to technical qualifications would also be advantageous. OPEX/ Lean six sigma green/black belt qualified or equivalent.
Other Benefits include:
1. Excellent opportunities for career enhancement and personal development.
2. Competitive base salary.
3. Annual bonus linked to business results.
4. A well-established further education program.
5. Pension scheme.
6. Private Healthcare.
HOW TO APPLY?
Make a difference today! Suitable candidates should apply for this role by emailing your CV to Paula O’Doherty, HR Director, paula.odoherty@skbiotek.ie
Closing date for applications is the 5th of February 2025.
SK pharmteco SM Europe is an equal opportunity employer.
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