Description. Scope of Function. . Under limited supervision, execute and provide data analysis of Client product tech transfers and assay verifications for the Analytical team. Provide analytical support testing, as needed, to GMP manufacturing, Upstream Processing, Downstream Processing and Bioconjugation groups. On occasion, collaborate with QC in performing method transfers as well as with troubleshooting existing qualified/validated assays. S...
Description. Scope of Function. . Under the supervision of the Department Manager, assist with the execution and analysis of client product tech transfers and assay verifications for the Analytical team. Provide analytical support testing, as needed, to Quality Control, Protein Characterization, and Micro groups. On occasion, collaborate with Material Management, CTOs, Purchasing, and Manufacturing departments in preparing solutions, managing lab...
Description. . In this role, you will be instrumental in producing clear and concise documentation for a range of pharmaceutical projects. The ideal candidate will possess a robust background in technical writing, exceptional attention to detail, and a profound understanding of pharmaceutical terminology and processes. . Specific Duties. Collaborate closely with cross-functional teams to collect information and gain a comprehensive understanding ...
Description. Scope of Function. Work within the Analytical Chemistry area to provide analytical support, test results and qualification of analytical methods and stability studies for clients in pre clinical and clinical development. Work with process development and manufacturing groups by providing QC support to assess the purity, potency, strength and stability of in process and final vialed product. Specific Duties. Understand and perform a ...
Description. . Specific Duties. . Supports and leads the design, development, and qualification/validation of analytical methods intended to assess critical quality attributes of raw materials, drug substances, intermediates, and products. Ensure evaluation and testing of GBI products are performed in accordance with regulatory standards, and scientific best practices and are completed on schedule. Participate in developing and managing stability...
