Vacancy R&D Director – Utrecht
25 OCT ’22: For a start-up organisation, that is developing a unique innovative class III medical device, we are seeking a Head of manufacturing. This Utrecht based start-up is currently working on a highly innovative product with strong quality and safety standards. This company produces its products in cleanroom environments and the production processes are subject to the applicable industry standards and regulations for the medical devices industry.
The goal of this position is to prepare the manufacturing process of the company’s lead product for clinical and commercial manufacturing, building on the existing manufacturing processes that are already in place. You are responsible for performing the company’s process and test method development activities. setting up and maintaining a validated manufacturing process and corresponding QC methods. Together with the team, you are responsible for:
- Ensuring that the company’s facilities and equipment, including a clean room environment, are qualified and maintained according to procedures;
- Coaching and training of team members;
- Ensuring that adequate procedures and sufficient resources are in place to perform production processes;
- Transfer of newly developed products from research to manufacturing.
Do you have experience in a similar position performing and managing process development and/or validation/manufacturing in the pharmaceutical or medical device industry? For this position we are looking for a professional with the following skillset:
- MSc or Ph.D. in Chemistry or related field, with a background in polymer science and/or particle formulation preferred.
- Affinity with both chemical synthesis and analytical techniques.
- Experience with working in a cGMP and/or ISO13485-governed manufacturing environment, and familiar with relevant regulatory guidelines.
- Experience in preparing documentation for validation of processes and test methods, development planning and reporting, as well as supporting regulatory submissions from a technical perspective.
Are you looking for an organisation with a dynamic working atmosphere, with an informal culture and after-work drinks, and other fun activities? In this function, you will work with a highly innovative product. Furthermore, this organisation can offer you the following in return:
Short lines of communication with for example the CEO;
- The clean room located next to the office;
- Scaling up a self-developed polymer;
- Competitive salary.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
+31(0)6-57 74 13 79
+31 23 754 86 60