Work for an Organization that brings innovative therapies to patients worldwide!
The Process Development (PD) department is an essential part of the company which is taking the lead for the in-house development, scale-up and manufacture of novel gene therapies. The downstream processing (DSP) team is responsible for the recovery and purification of the biopharmaceutical from the bioreactor harvest through a sequence of unit operations, including cell lysis, filtration, chromatography and UF/DF. The DSP team will also support tech-transfer to Contract Manufacturing Organizations (CMOs) to support the manufacture of AAV-based gene therapies for clinical trials.
Main responsibilities of the role:- Design and optimize the downstream manufacturing process.
- Apply Design of Experiments (DoE) to aid efficient process development and use of Quality by Design principles.
- Conduct process development at small scale of each unit operation (processing 2 – 16 L harvest).
- Scale-up and further optimize the manufacturing process to pilot scale (processing 50 L harvest).
- Manage the technical execution of projects to meet the set timelines and deliverables.
- Oversee the day-to-day execution of downstream process development activities through a combination of hands-on work and supervision of technicians.
- Write SOPs and document the work in study plans and reports. Draft manufacturing documentation.
- Support the implementation of an EDMS.
- Secure data management, processing of the results and presentation to key stakeholders.
- Develop training plans and mentor (junior) technicians and students.
- Contribute to the maintenance and housekeeping of the small and pilot scale laboratory equipment and a safe laboratory working environment.
- Work collaboratively with scientists in Upstream Process Development, Vector Development and Analytical Development.
You will report to the CFO and work closely together with external service providers (accounting and audit) and internally with your colleagues to build and maintain a thorough understanding of our projects and the biotech business.
Minimum Requirements:- PhD, with a minimum of 2 years of relevant working experience.
- Hands-on experience with small scale chromatography and ultrafiltration equipment required, preferably with AKTA systems.
- Industrial experience with development of the manufacturing process for biopharmaceuticals, such as vaccines or gene therapies is considered a plus.
- You are thorough and have an eye for detail. You deliver highly precise work and work consistently and at a steady pace.
€55000 - €90000 monthly