Head of Process Development at HAL Allergy
The Head of Process Development is responsible for all aspects of process development for HAL Allergy including the development and optimization of manufacturing processes for multiple product lines and the development and application of enabling technologies. The department (about 10 FTE) is composed of scientists and technicians working on enabling technologies such as extraction, (ultra-) filtration, chemical modification, formulation and lyophilisation. The teams consist of (sr.) scientists, process developers and technicians. Besides the management of the department, the role holder will provide scientific oversight into the process design and technology transfer to GMP operations and will ensure that the process development activities meet the business and regulatory needs of HAL Allergy.
- Develop and maintain the department to ensure that the process development capabilities are aligned with the company’s business and ambitions.
- Lead and coach a team of motivated (sr.) scientists and technicians.
- Plan and prioritise work of the department, and co-ordinates that of direct reports, in line with corporate business targets and to ensure that deadlines are met.
- Ensure high-quality of the work performed by the department and make sure that new and improved manufacturing processes comply with relevant regulatory guidelines (e.g., GMP and ICH).
- Apply QbD and DoE principles to various projects/product developments and validations where applicable.
- Validation of DS and DP manufacturing processes.
- Ensure optimal and effective co-operation with other departments such as Analytical Development, Technology Transfer, Operations, QA/QC and Regulatory Affairs, and maintain oversight of technology transfer to Operations and supply of process development documentation for regulatory submissions.
- Keep up to date with the frontiers in (allergen-specific) process technology developments and ntroduce new enabling technologies where considered required.
- Ensure high-quality input of the department in multidisciplinary projects by delivering and executing process development/improvement strategies for new and existing products in compliance with the projects milestones and timelines.
- Provide regular progress reports (verbal and written) and ensure documentation of study plans, results and reports.
- Involved in operational and tactical decision making; use knowledge and experience to make independent recommendations and informed decisions on a daily basis relating to issues within own area of responsibility and expertise.
- PhD degree in natural sciences, bio-processing (or equivalent) with a minimum of 8 years of relevant experience in pharmaceutical product development.
- Pro-active team player, a motivator and good communicator, and hands-on mentality.
- Experience with separation technology including extraction, chromatography and tangential flow filtration.
- Experience with tech transfer from development to GMP production.
- Experience with regulatory scientific writing of manufacturing development and validation modules.
You are a strong manager who can collaborate, motivate people and are able to negotiate if needed. You are result driven and take ownership and accountability. You have strong scientific knowledge and autonomy, as well as analytical skills. You oversee complex problems and make sure to solve them.