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:
Make study designs to develop and optimize the downstream manufacturing process
Apply Design of Experiments (DoE) to aid efficient process development and use of Quality by Design principles
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
Manage the day-to-day execution of downstream process development activities through a combination of hands-on work and supervision of technicians
Write SOP’s 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.
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 in a steady pace.
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