Participate in the development and optimization of downstream processes for the production of biologics at different clinical stages, as well as assist in the development of a next generation downstream manufacturing platform.
PD scientists and engineers contribute to cross-functional teams to meet highly visible business objectives.
Design and execute protocols to solve process-related manufacturing investigations and drive process improvements by using laboratory and pilot scale-down models in protein chromatography, viral inactivation, viral filtration, ultrafiltration/diafiltration, membrane filtration, depth filtration, and centrifugation.
Document experimental data and results, verify and interpret data with respect to the laboratory protocol and manufacturing process.
Evaluation of new process technologies, including multicolumn continuous chromatography (MCC) operation.
Characterization of products and impurities.
Buffer preparation and column packing.
Appropriate GLP/GMP procedures must be followed.
MS or BS in Biochemistry, Chemical Engineering, or related field with 2–4 or 4–6 years, respectively, of relevant industrial and/or academic experience.
Knowledge of protein purification, protein stability, and demonstrated experimental skills for laboratory work are required.
Experience with AKTA purification operations and UNICORN method writing is helpful.
Experience with process scale-up/scale-down and process characterization is a plus.
Critical qualities include a high degree of initiative, good verbal and written communication skills, strong scientific skills and attention to detail, and the ability to work in a team environment.
Experience using Affinity chromatography, CEX, AEX, and HIC is highly desirable