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Biologist as scientist (m/f/d)

Jülich
Glycothera Development GmbH
Scientist
Inserat online seit: 25 Juli
Beschreibung

GlycoThera Pharmaceutical Services is a leading global service provider for contract development and analytics for biotherapeutics at all stages of product life cycle. With our expertise in the development of biologics (recombinant proteins such as monoclonal antibodies, cytokines and hormones), manufacturing sciences, analytics, quality control and regulatory strategy we support a broad range of clients globally, from emerging biotech startups to leading global pharmaceutical companies. For our site in Julich (Germany) we are looking for several highly motivated scientists to join our Downstream Process Development team. The main area of responsibility will be the development of downstream processes intended for the manufacture of recombinant proteins under GMP. Scientist (m/f/d) Downstream Process Development (full-time, permanent) The Julich site focusses on small-scale process development for the manufacture of recombinant proteins up to readiness for transfer into pilot scale. A new team will be established at the site for downstream activities. The team will be integrated seamlessly into the drug substance development workflow and benefit from close collaboration with cell line development, USP and a high-class analytical infrastructure to achieve a targeted, high-throughput development. Independent planning, execution and documentation of small-scale purification experiments Adequate documentation of all work according to quality standards Application of quality by design principles to achieve project goals like specific product quality profiles or enhanced process yields Evaluation of unit operation performance as well as product quality results against agreed targets to plan subsequent project steps Presentation of main results and project status in internal or external meetings Support of tech transfer activities to the customer (technical documentation and potentially on-site support) Maintenance of databases and data mining Training and supervision of lab technicians Ensuring proper functionality of the downstream lab Support the team with occasional weekend duties Master in Biotechnology, Biology or other relevant education with several years of work experience in the area of downstream process development Hands-on experience, scientific knowledge, and end-to-end understanding of downstream purification of monoclonal antibodies and recombinant protein therapeutics. Knowledge/experience of running and reporting complex experiments. Experience with process characterization. Proven experience of collaborative team-working. Ability to report technical information in a written and verbal format. Sound understanding of major steps involved in the development of biopharmaceuticals (process development, process lock, scale-up, tech transfer and process characterization, process validation) Hands-on experience with common downstream techniques (ProA, VI, CEX, AEX, HIC, MMC, TFF, column packing), ideally experience with both, batch and continuous mode of operation Hands-on experience with common devices like Äkta avant/pure, Tecan, KrosFlow or similar,, incl. respective software Sound statistical knowledge and experienced in the use of statistical software like JMP and MODDE, SIMCA Ideally experienced in protein characterization Familiar with common quality principles (GMP, ISO:9001, ALCOA) You are a smart, proactive and solution-driven scientist with a hands-on attitude who is able to independently progress projects, prioritize tasks adequately and work against tight timelines. At the same time you maintain a high quality standard in your work, support the team and foster a sense of positivity. The team´s success is your success Language: English, German is highly beneficial. Industrial experience: Industrial work experience (biotechnology/biopharma) is highly appreciated. Our Julich site with currently 40 employees offers an innovative, vibrant and multicultural environment that gives you the chance to bring in your competencies, and together with a highly motivated team drive the change and develop personally. We believe in a culture of respect, trust, reliability and positivity.

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