QC Analyst, Raw Materials
Semma Therapeutics Inc (inactive)

Job Info

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In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat-and even cure-several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

Key Responsibilities

• Execute raw materials release testing, including appearance and identity testing
• Execute raw materials stability testing
• Work with Quality Assurance to update Raw Material Specification Sheets on an as needed basis
• Provide stability reports for every raw material
• Perform product and drug substance release and stability testing as needed
• Work effectively as a part of a QC team
• Provide basic troubleshooting for testing and equipment and process
• Other duties as assigned

Basic Qualifications:

• Bachelor's degree with 3- 4 years' experience in analytical testing for a GMP therapeutic program (FTIR, LC-MS, GC-MS, ICP, etc)
• Prior experience using FTIR

Preferred Qualifications:

• Experience performing QC tests for a GMP cell therapy program, including flow cytometry, PCR, ELISA
• Experience performing LC-MS and GC-MS, Karl Fischer and TGA in a QC environment. Experience executing USP chemical identity tests for raw materials. Experience setting up stability programs for raw materials.

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