We have an exciting opportunity for Oral Solid Dose Commercialisation Technical Lead to join our Ballydine team. Reporting to the Pharm Technical Head of Commercialisation Development and Supply (CDS), the incumbent manages the provision of technical support to the Ballydine Potent & Continuous Oral Solid Dosage (OSD) Processing facility. This includes the support of the ongoing Capital project and the preparation of site systems for the subsequent Commercialisation (new product introductions). The incumbent is also responsible for discovering, developing, and implementing the design & process improvements and for the provision of technical support to the Integrated Process Team (IPT).
Tasks and responsibilities include but are not limited to.
- You will stay up to date with the latest developments in CMa (Continuous manufacturing) and Potent Processing, both within our organization and externally. You are expected to use this knowledge to coach your colleagues and help achieve our overall divisional goals.
- You will be responsible for creating and prioritizing development plans across multiple site systems. This includes working proactively with leaders in other functions such as Quality, Analytical Development, and Integrated Process Team (IPT) to ensure our site systems are optimized across multiple groups to maximize our impact on the project portfolio.
- You will provide direct technical support to the Capital project throughout remaining CQV activities & subsequent CV (Containment Verification) activities. You will also provide technical support to the development & implementation of Site systems for both clinical, and commercial supply production for our future Potent and / or CMa processes.
- You will direct the technical support for process development activities associated with new processes in Development, Clinical Supply, and Process Performance Qualification through to Supply. This requires a full understanding of the process/formulation and engineering issues associated with new Continuous or Potent processes.
- You will coordinate the technical resources needed to support the Capital project in achieving project targets by managing the impact of changes and ensuring a timely and compliant closure of issues and incidents.
- You are responsible for ensuring that all work is conducted safely and in compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
- You'll also be expected to develop the Technical team by delegating tasks, providing feedback, and assisting in the provision of opportunities for professional growth.
- You will be accountable for ensuring assigned processes/systems managed are carried out in conformance with site divisional and corporate quality standards, and that all deviations from standards are thoroughly investigated and corrected.
Your profile
- We require a BSc/BEng or higher in Chemistry, Manufacturing, Engineering, or a Science discipline.
- A minimum of 10 years of relevant industry experience. A significant portion of that time focused on Continuous Manufacturing; Potent Processing & associated control systems is a must. You should be well-versed in the processes, engineering principles and formulation development techniques specific to CMa. Familiarity with process, equipment, and cleaning validation, as well as cGMP's and regulatory requirements, is required.
- You should have a thorough understanding of Capital project systems such as CQV, Containment verification, & Change controls.
- You should have a thorough understanding of production operations, Operating Procedures, & Recipes.
- Along with technical expertise, you should possess productive communication and interpersonal skills, demonstrated ability in strategic thinking and problem-solving, and have a clear understanding of financial management. Project management skills, customer service skills, and efficient time management will be value-adding traits.
- You should have the ability to work in partnership with site functions and external partners, including PCT, and our Manufacturing Division groups in areas related to Potent Processing and CMa including process development, process equipment, process operations and validation. We need someone who can communicate effectively, evaluate projects technically, and manage a diverse range of projects in a changing environment.
- Above all, we value honesty, respect for people, and commitment to ethical behaviour. You should be able to demonstrate an ability to embrace diversity and inclusion, and always put patients first.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
