As the Manager Process Technology and Scale Up, you ensure that PDS develops new innovative technologies, processes and products through each stage of pharmaceutical development that meet the clients expectations and in a commercial phase can be robustly manufactured by operations, in a G.M.P. environment.
The team lead is responsible for the daily planning of the pilot line, the supervision and execution of product and process trials, scale ups and transfers.
As a subject matter expert the team is an essential contact for all new / adjusted processes and equipment, leading and participating in local and global project teams.
Manage pilot plant facility and equipment;
Full responsibility for execution of IMP batches;
Full responsibility for batch documentation;
Act on the results of R&D trials and scale up batches to recommend improvement in the manufacturing process where required;
Attend / participate weekly multi-department review meeting (DNR) to prepare weekly trial, scale up and transfer overview based on set priorities and available resources;
Plan and monitor the progress of trials within the pilot plant and if required to co-ordinate and discuss the reallocation of resources with the Operations group to ensure smooth transfer of trials;
Provide active feedback to Formulation Department and customer to make a positive contribution to the development of new products and technologies;
Keep the pilot plant procedures and operation in compliance with current cGMP and FDA guidelines;
Drive OE within PTS team.
A MBO+ (MBO with an extension of a professional specialised pharmaceutical or process related course) or HBO as well as a minimum of 10 years of experience at a minimum level of a Sr.
operator in the field of a softgel manufacturing process in a cGMP environment;
Extensive experience in solving and analysing problems;
Supervising experience is preferred;
Ability to communicate in Dutch and English to enable effectively write research reports, business correspondence and to present information and respond to questions from both internal and external customers.