· Plan and perform early developability and pre-formulation assessments (e.g., stress testing, formulation screening, and phase-appropriate stability studies) using biophysical and analytical tools (such as DSC, DLS/Zetasizer, particulate analysis, SEC and related techniques) to enable lead candidate and formulation selection.
· Design, plan, and execute formulation and process development studies for biological drug products (e.g., sterile injectables, lyophilized products, multi-dose vials, and other presentations).
· Implement and oversee automated equipment/workflows to improve efficiency.
· Support the manufacturing of materials for early clinical trials by performing aseptic filling, utilizing single-use systems, peristaltic pumps, and small-scale filling assemblies.
· Anticipate and resolve key technical and process-related challenges to meet project timelines and deliverables.
· Analyze complex data sets, draw clear conclusions, and provide timely feedback and recommendations to enable data-driven formulation decisions.
· Document experimental work in electronic lab notebooks and author concise technical reports and presentations to support internal decision-making and, as appropriate, regulatory submissions.
· Collaborate closely with downstream/process development, analytical sciences, device/packaging, manufacturing, and quality teams to translate laboratory findings into robust, scalable drug product processes.
· Contribute to continuous improvement of formulation development workflows, analytical capabilities, and laboratory practices, including evaluation and implementation of new technologies where appropriate.