Scientist Process Development at HAL Allergy
As a scientist you are responsible for the development and optimization of manufacture processes for a specified product line. You lead a small team of developers / technicians and will represent the team in interactions with other departments, such as Operations, QA/QC and Regulatory Affairs.
As a Scientist within HAL Allergy you develop and optimize the manufacture processes for specified products and make sure that these new or adjusted processes are transferred to Operations. As a knowledgeable expert you act as a consultant for technical questions relating to the specified product lines and technologies. By leading a team of motivated process developers, you form a center of (technical) expertise on the specified product line. In this role you participate in multidisciplinary project teams.
You ensure high-quality of the work performed by the team and make sure that new and improved manufacturing processes comply with relevant regulatory guidelines (e.g. GMP). You coordinate your own work and that of direct reports, in line with corporate business targets and deadlines.
You provide regular progress reports and ensure documentation of study plans, results and reports. In operational decision making, your knowledge and experience is used to make independent recommendations and informed decisions on a daily basis.
You have a master degree in natural sciences, bio-processing or food technology with a minimum of three years relevant experience in pharmaceutical product development. You have experience with separation technology, including extraction, chromatography and tangential flow filtration. Experience with upstream processing is a pre.
Tech transfer from development to GMP production is not new to you and you have a good understanding of relevant regulatory guidelines pertaining to the development of therapeutic allergen products.