Responsibilities: ⢠Produce lab-scale new or customer formulations to be later scaled for production ⢠Work with procurement team to source and select materials compatible with product design, regulatory requirements, and process capabilities ⢠Work with process engineering to design and develop transferable and scalable processes for existing production equipment ⢠Deliver well-documented, dynamic design control for all products, meeting ISO 13485 and internal Scapa procedural requirements (e.g., PLM, Design Control, etc.) ⢠Execute with cGMP per 211 FDA guidelines for pharmaceutical practices ⢠Maintain compliance with relevant GMP, GLP, health, and safety requirements ⢠Create analytical test methods as required ⢠Perform chemical testing on samples using physical characterization and advanced instrumentation techniques, including Microscopy, FTIR, HPLC, viscosity, specific gravity, pH, etc. ⢠Interpret the test data independently or with guidance to make sound technical evaluations for quickly resolving quality issues related to raw material issues, manufacturing challenges, and consumer complaints ⢠Design and execute experiments to help improve the current testing procedures or develop new protocols ⢠Routine testing of raw material, bulk batch, packaging, and stability samples ⢠Ability to communicate test results effectively ⢠Document all the results by following company policies, scientific best practices and GLP practices ⢠When applicable, manage internal process improvement projects, including but not limited to raw material qualification, cost savings and production process improvements.