Quality Control Analyst

This candidate will be responsible for laboratory activities in support of process development and industrialization and ensure the characterization of mRNA. These analyses include HPLC, ELISA, qPCR, western blot and more that support the process development.

Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory
• Conduct experiments using sterile techniques
• Execute routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE
• Execute routine procedures based on bioassay methodologies, such as plate based assays (ELISA, qPCR, ddPCR, ribogreen), gel electrophoresis, western blot and cell based assays
• Support laboratory start-up activities
• Participate in validation activities
• Participate in continuous improvement of laboratory safety and quality compliance
• Execute troubleshooting with guidance of supervisor or senior team members
• Support lab investigations as needed
• General laboratory activities and instrumentation including: pipetting, preparation of solutions/samples/media, and operation of pH meters, autoclaves and analytical balances
• Assist with the development of new methods and processes
• General laboratory upkeep and supplies maintenance

• Minimum requirement: BS degree in analytical Chemistry, Biochemistry, Biotechnology or a related discipline
• UPLC and HPLC and/or ELISA and PCR expereince
• Preferred 0-2 years of xperience in cGLP or cGMP lab strongly preferred
• Preferred knowledge of software (LIMs, Empower, Bio-Rad Image Lab)
• Good deductive reasoning and analytical approach to problem solving
• Able to handle multiple projects concurrently, self-motivated, and results driven
• Able to communicate effectively
• Time management skills
• High level of independence after the training phase
• Good organizational skills, record keeping, and follow-through will be integral to success

IND2