Senior Associate, QC Microbiology
Cambridge, MA | Contract
The Quality Control Microbiology Senior Associate will support microbiological method transfer, qualification and release testing for GMP QC raw materials, drug substance and finished product testing for mRNA products produced at client’ s manufacturing facility and affiliated contract organizations. He/she will contribute to the implementation of QC Microbiology testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting. This position will have a primary focus in supporting Quality Control testing in association with Personal Vaccine Unit (PVU). The position may require off-shift hours including nights and weekends.
Here’ s What You’ ll Do:
- Collaborate with development groups for method transfers and qualifications in support of expanding the GMP QC Microbiology laboratory capabilities to include: Rapid Sterility, Rapid Bioburden, Endotoxin, Culture Purity and Cell Stock Identity, Cell Density Determination, TOC and Conductivity Testing utilizing both standard and rapid methods.
- Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies
- Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
- Assist with equipment qualification / validation activities, including maintenance
- Troubleshoot issues related to equipment, laboratory procedures and assay performance
- Conduct technical assessments of deviations and investigations
- Write/revise SOPs, technical protocols and reports
- Offer input and suggestions for improvement in laboratory operations and procedures
- Train and provide technical guidance to other microbiologists