Executive Director Manufacturing Operations
Posted on Jan 6, 2021 by Real Staffing Group
Biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.
The company has a portfolio of medicines through its orphan and inflammation groups. The company's global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.
The company have ambitious plans and have an exciting opportunity for a permanent full time Executive Director, Manufacturing Operations (Large Molecules) based at the Dublin office.
Reporting to the Vice President, Manufacturing & Supply Chain, the Executive Director of Manufacturing Operations (Large Molecules), is responsible for the oversight of the manufacturing of large molecule commercial products through the company's network of contract manufacturing organisations (CMOs).
- The primary focus of this role is to ensure a stable supply of compliant products that meet all commercial and clinical patient demands through well monitored, robust manufacturing processes.
- Lead the Large Molecule manufacturing team and develop the capability of the team.
- Partner with the Quality function in the supply of compliant product and oversight of manufacturers.
- Partner with the Supply Chain function in the development of supply contracts and oversight of manufacturers.
- Partner with the Technical Development organisation and others in the transition of development products to commercial operations, technology transfers, complex process investigations and process improvements.
- Develop strategies and plans for the reliable manufacture and long-term manufacturing capacity of large molecule products..
- Control manufacturing costs to meet budget plans.
- Identify and execute opportunities for manufacturing and process improvements in collaboration with other functions.
- Ensures that manufacturing operations consistently meet cGMP and other regulatory requirements.
- Work in close collaboration with Technical Development, Quality, Supply Chain, Project Management, Regulatory Affairs, Finance and Legal colleagues to meet overall business and Technical Operations function goals.
- Participates in various cross-functional teams or committees, eg Quality Council, Supplier Review Board, S&OP, Budget Development and Review and all product related team meetings associated with large molecule commercial supplies.
Qualifications and Skills Required:
- Primary degree in Science or Engineering, in a related field or study of Pharmacy.
- 15+ years industry experience, with 10+ of those years in a large molecule manufacturing environment, 5+ of those years in a drug substance manufacturing environment, and 5+ of those years managing contract manufacturers of large molecule products.
- Thorough understanding of evolving best industry practices and regulations in manufacture of large molecule products.
- A proven team player and people leader with a demonstrated track record in the development of team members.
- A strong commercial orientation and the ability to be agile and mobilise others in the organization to initiate progressive change
- A good understanding of supply of contracts and associated legal issues.
- Experience of launching new products.
- Exceptional organisational skills in handling multiple priorities and meeting required forecasts, budget objectives, and milestones.
- Well-developed analytical, communication, and project management skills.
- Proven record for the successful implementation and a continuous improvement in a forward thinking organisation.
- Proactive professional with excellent leadership, and problem-solving capabilities.
If you are in interested in this role please apply immediately with an up to date CV. Not sure yet? No CV ready please give me a call for more information.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales