Duration: 6+ Months
• The role of the Research Scientist in Manufacturing Sciences & Technology, Downstream is to conduct experiments for the purposes of commercial manufacturing support for biopharmaceutical purification and bulk drug substance handling processes consisting of chromatography, viral inactivation, ultrafiltration/diafiltration, filtration and bulk scale cryogenics unit operations. Responsibilities include the operation, cleaning and maintenance of laboratory equipment, the preparation of buffers and reagents, documentation of experimental data and results, data verification and the preparation of study protocols and final reports.
• Appropriate GLP/GMP procedures must be followed. This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale through the effective design of scale-down studies and the evaluation of data from manufacturing lots. The successful candidate will work effectively in cross-functional project teams and also work independently to accomplish project goals. The position offers the opportunity to interface with Process Development, Pilot Plant, Manufacturing, Manufacturing Support, Quality Assurance, Analytical, Supply Chain and Global Regulatory Sciences groups. Strong communication and technical writing skills are required.
• Responsible for the transfection, amplification and sub cloning of cell lines for the isolation and selection of stable high antibody-expressing clones. Responsible for the maintenance and expansion of mammalian cell lines using aseptic technique. Responsible for the cryopreservation of cell banks. Maintain detailed and accurate notebook documentation for all research activities. Perform routine titer evaluations. Responsible for assisting in the preparation, storage, packaging and shipping of cell lines and samples. Maintain working knowledge of current cell culture literature. Assist in all areas of cell culture and all related duties as required.
• B. S or M.S. degree in Biological or Chemical Sciences / Engineering preferred. Knowledge of protein purification, protein stability, protein formulation and demonstrated experimental skills for lab work are required. Applied knowledge of AKTA purification, preparative chromatography systems, and ultrafiltration/diafiltration operations are helpful. Candidates must possess good organizational skills and strong attention to details, excellent experimental/troubleshooting aptitude, and be self-motivated. The candidate should also possess good verbal and written communication skills, as well as excellent interpersonal skills with the ability to work in a team environment.
• Requires a BSc in biology or chemistry, with a minimum of 2 years of experience in mammalian cell culture with a 1 year minimum in an industrial environment. Previous experience with bioreactors is preferred. Previous experience with Clonepix Fl technology is also a plus. Hands-on lab work in a flexible, fast-paced entrepreneurial environment is essential.