Quality Control Technician

Position Summary:

·      Authors and manages change controls, material enrollment forms, product evaluations, risk assessments, SOPs, and other documents to support enrollment of raw materials and critical reagents for clinical trials under limited supervision/guidance.

·      Provides support to supply chain and process to ensure all documentation required for materials and critical reagents to be used in the manufacturing and testing of CTM.

·      Serves as interface between vendors, TD, Supply Chain, and Process Development, and represents TD department in cross-functional forums to support manufacturing and QC

·      Works closely with a cross-functional team to deliver necessary documentation.

·      Evaluate material to determine if additional testing is required upon receipt of material and coordinate with appropriate analytical teams.

Requirements:

·      B.S. in Biology, Analytical Chemistry, Biochemistry, Biomolecular Sciences or related with 1-2 years of industry experience

·      Experience in biotech or pharmaceutical development in one or more of various disciplines including (but not limited to) Analytical Chemistry, Biochemistry, Biomolecular Sciences, etc.

·      Support analytical testing as necessary to support the sa-mRNA program (gel electrophoresis, capillary electrophoresis, plate-based assays, and other DNA/RNA/LNP methods)

·      Utilizes knowledge and experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing

·      Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work