Process Developer at HAL Allergy
HAL Allergy is a modern company with high quality pharmaceutical GMP manufacturing and research facilities located in the Leiden Bio Science Park. With offices in seven European countries, we are one of the top European players in the field of allergy diagnostic and treatment. Since 1959 we have gained experience in developing, producing and selling allergy therapies for the treatment and prevention of allergic diseases. These immunotherapies are used primarily against common allergies such as hay fever, house dust mite allergy and allergic reactions towards wasp or bee stings. Beside the development and production of allergy vaccines, HAL Allergy started a new business in 2012. This new Contract Manufacturing Organization (CMO), named HALIX, is engaged in the production of biotechnological products for preclinical and clinical studies. HAL Allergy Group is a mid sized company with headquarters in Leiden. We employ around 300 highly specialized people across various roles. The departments at our headquarters include development, production, quality assurance and control, clinical and registration. Our staff work closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities
Process Development is a department within the R&D unit, which focuses on the development of manufacturing processes of allergen preparations for therapeutic and diagnostic use. The department is consists of expertise teams working on the process development for HAL Allergy’s existing products, new product candidates and/or on enabling technologies such as formulation and freeze-drying.
The Developer is responsible for the development and optimization of manufacture processes for a specified product line. The Developer will be involved in technology transfer of the production process to GMP operations.
Tasks and responsibilities
- Development and optimization of the manufacture processes for specified products;
- Identify critical process parameters of production processes;
- Tech-transfer of new or improved manufacturing processes to Operations;
- Contribute to trouble-shooting with respect to production processes, and initiate improvements;
- Deliver high-quality of the work and make sure that new and improved manufacturing processes comply with relevant regulatory guidelines (e.g., GMP);
- Report experimental results.
- BSc degree in natural sciences, bio-processing or food technology (or equivalent) with a minimum of three years relevant and recent experience.
- Experience with separation technology including extraction, chromatography and tangential flow filtration.
- Pro-active team player, good communicator, and hands-on mentality.
- Proven experience with tech transfer from development to GMP.
Personal & Professional Skills
- Critical thinking and problem solving
- Goal oriented and result-driven
- Team player
- Excellent communication skills, both in Dutch and English
- No 9-5 mentality