Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Specialist will support microbiological method transfers, qualification and release testing for GMP QC raw material, drug substance and finished product testing for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations. The QC Microbiology Specialist uses expert knowledge of cGMP regulations and QC Microbiology processes to manage investigations and improvement initiatives within QC Microbiology operations.
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 including both standard and rapid methods.
- Utilize QC Microbiology knowledge and investigational skills to identify and resolve testing issues and drive continuous improvement in laboratory operations.
- Lead special projects as Microbiology SME in support of clinical operations
- Conduct technical assessments of laboratory data, deviations and investigations
- Write/revise method SOPs, technical protocols and reports
- Support testing for raw materials, 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
Here’s What You’ll Bring to the Table:
- BS in a relevant scientific discipline with a minimum of 4 years Quality Control experience in a cGMP organization with a focus in Microbiology
- Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
- Knowledge of Vitek, BET, MODA, Rapid Microbiological Methods, and/or Isolator Sterility Testing and Technology
- Demonstrated knowledge of method development, method qualifications, and compendial method verifications
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
- Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Excellent communication skills (verbal and written)