Process Development Director
An exciting opportunity for an experienced leader to be a key member of the Site Leadership Team supporting the GM and SLT in all aspects of the operation and in strategic planning.
Responsible for owning the process and analytical development activities within the business and a growing team currently at circa 65, ensuring that the process is appropriate for manufacture for the phase of development or product lifecycle.
The role combines knowledge of scientific and business issues to enable products that are developed, manufactured or distributed to meet all required legislation.
The leader will develop, mentor, and supervise professionals within this business area.
Duties and Responsibilities:
· Show Strategic Leadership and clear vision for the group embracing change and continuous improvement whilst motivating and developing the strong management team in place.
· The team will be key in interfacing with the customer during the development and technology transfer phase of a project. This includes the technology and analytical transfers of the products to the site.
· Process development of the products to ensure that the process is appropriate for manufacture for the phase of development or product lifecycle.
· Analytical development of the methods for testing of raw materials, intermediates and APIs as appropriate for the phase of development or product lifecycle.
· Process validation of new products and lifecycle changes. Responsible for the generation of the control strategy and validation and the supporting analytical methods.
· Transfer of products to Operations post commercial validation. PDS is responsible for ensuring that the process is fit for commercial manufacture.
· Transfer of methods to QC for testing of raw materials, intermediates and API at all phases of the product lifecycle. PDS is responsible for ensuring that the methods are appropriate for the phase of development or product lifecycle.
· Transfer of methods to IPC for in-process control testing of processes at all phases of manufacture and lifecycle. PDS is responsible for ensuring that the methods are appropriate for the phase of development or product lifecycle.
· Ensure that the basis of safety is in place for all products and that the appropriate safety testing has been completed for all.
· Material science characterization support and crystallization support
· Technical and analytical troubleshooting and improvements, as required
· Ensure the team stays up to date with current technologies and manufacturing trends.
· Confirm a robust succession plan in the team for key roles.
· Make sure that there is a strong quality, EHS, PPI and compliance culture across the team.
· Managing the team Opex budget and supporting the planning of the capital requirements for the future.
· Minimum requirement of B.Sc Chemistry or B.Eng Chemical Engineering. It is preferred candidates would hold a M.Sc/M. Eng or Ph.
· A decisive leader who’s able to encourage and empower teams and can clearly communicate goals and objectives.
· A visionary leader who embraces continuous improvement and transformational change
· Extensive experience in Pharmaceuticals, API manufacturing, BioPharma or similar
· Working knowledge of CDMO would be an advantage
· Experience in technology transfer and process development
· Practical knowledge leading multi-disciplinary teams at a Senior level
· Experience in budget management
For a confidential discussion and more information on the role, please contact Rory Walsh.