Downstream Process Development Professional

Job Description

Support the DSP team with basic activities such as preparation of buffers and reagents. Designing of purification processes for novel fusion antibodies; antibody fragments and other new formats. Planning and execution of experiments associated with process development, late phase process optimization, process characterization activities. Interaction with relevant cross functional team for smooth functioning of the daily activities. Regular documentation of experiments contemporaneously in electronic lab notebook. Compilation of experimental data for further evaluation. Authoring technical reports and communicating the key findings. Participating in the weekly team meetings. Actively involve in scale-up and technology transfer to manufacturing. Troubleshoot recipes in purification systems -AKTA Pure, AKTA pilot & TFF System and develop long-term solutions for the betterment of purification platform. Enable the team in procurement of raw materials and consumables and in lab maintenance and remove any obstacle in maintaining lab inventories. Author, review protocols, reports, scale up & scale down studies, tech transfer documents, deviation & OOT reports and executed BMRs. Actively participate in quality related investigations and propose effective corrective and preventive actions. Ensure compliance in issuance of lab notebooks and archival of records such as logbooks, lab notebooks, protocols, reports, documents in electronic management system. Well versed with Track wise or similar QMS systems. Education and Experience Education Master s degree in Life Science, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 2-4 years of relevant practical experience in downstream process development specifically with monoclonal antibody purification Other competencies required for the role Basic knowledge of downstream purification principles is essential for this role. Proficient in handling of AKTA Systems or equivalent. Experience in scale-up and tech transfer is preferable Experience in using electronic lab notebook, Electronic Database Management System (EDMS), TrackWise is preferable not mandatory.