Scientist Downstream Process Development (DSP) – antibodies and gene therapy
Work for an Organization that brings innovative therapies to patients worldwide.
Our client combines the potential of antibodies and gene therapy to develop long-lasting therapeutic solutions for disease areas of high unmet medical need.
Founded in August 2020, and based in the Amsterdam Science Park, our client is a fully integrated gene therapy company focused on the development of innovative therapeutics.
With R&D facilities in Amsterdam, our client develops proprietary & partnered programs based on its novel AAV-based vectorized antibody gene therapy platform. Next-generation vector technologies are applied to develop product candidates, which will enable a proprietary and highly scalable manufacturing process.
Your position within the organization
The Process Development (PD) department is an essential part of our client, 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) for 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 the 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 day-to-day downstream process development execution by a team of technicians
-
Manage the technical execution of projects to meet the set timelines and deliverables • Develop training plans and mentor (junior) technicians and students
-
Write SOPs and document the work in study plans and reports. Draft the manufacturing documentation
-
Secure data management, processing of the results, and presentation to key stakeholders
-
Work collaboratively with scientists in Upstream Process Development, Vector Development, and Analytical Development
Skills and Qualifications:
-
Ph.D., with a minimum of 2 years of relevant working experience
-
Hands-on experience with small-scale chromatography and ultrafiltration equipment is required, preferably with AKTA systems
-
Industrial experience with the development of the manufacturing process for biopharmaceuticals, such as vaccines or gene therapies is considered a plus
-
Experience in upstream processing is considered a plus
Your Natural Strengths and Drivers
You are thorough, have strong scientific and organizational skills, and have the ability to distinguish main priorities from lower-priority matters. You deliver well-thought-through study designs and work consistently and at a steady pace.
Working at VectorY
We offer an attractive salary package, 30 holiday days, and every opportunity to develop yourself. A personal and authentic experience within a young, ambitious biotech company with a strong and established infrastructure on the path to bringing innovative therapies to patients worldwide.
Please feel free to contact Albert Peters for more information via albert@2mrecruitment.com OR +31628209882