In this role, you will play a pivotal role in planning, executing, and documenting laboratory-scale downstream purification unit operations and drug substance intermediate (DSI) hold and stability studies. You will be directly responsible for the operational management of critical stability programs, including aseptic aliquoting, temperature-controlled sample logistics, sample accessioning, coordination with testing laboratories, and inventory management. You will work closely with senior scientists and engineers across the department and cross-functional teams to qualify purification processes, troubleshoot technical deviations, and deliver high-integrity datasets that safeguard commercial supply.Key Skills Required:Demonstrated hands-on laboratory experience with bio-separation and downstream purification unit operations: column chromatography (ÄKTA / Unicorn software), Tangential Flow Filtration (UF/DF), and/or depth filtration.Rigorous understanding and demonstrated execution of aseptic techniques in biosafety cabinets (laminar flow hoods) for sterile sampling and aliquoting.Working knowledge of sample management workflows, inventory controls, and stability study execution.Familiarity with analytical tools for protein/biomolecule quantification (e.g., SoloVPE, UV-Vis spectrophotometry).Strong aptitude for statistical analysis, data handling, and experimental design (experience with JMP, Minitab, or advanced Excel is essential).High level of attention to detail and adherence to Good Documentation Practices (GDP) and data integrity principles.Excellent interpersonal, verbal, and written communication skills with the ability to articulate technical observations effectively within a matrixed team.
