Overview In this role you will conduct and manage microbiology research and method development for established and new products. You will work closely with R&D and QC Microbiology to validate methods, perform investigations, and support cGMP data generation. You will plan projects, ensure quality and timelines, and contribute to programs like validation and environmental monitoring. This position offers hands-on lab work in a GMP setting with impact on product development and regulatory submissions. You will collaborate cross-functionally to deliver development summaries and client-ready documentation.
Responsibilities- Develop and execute investigations and method validations for microbiology projects
- Perform microbiological tests and support Environmental Monitoring and QC activities
- Generate and document cGMP data and supporting reports
- Plan and manage research projects, including validation and transfer activities
- Participate in cleaning, process, and equipment validation programs
- Read and document media fill results and contribute to development summaries
- Ensure client and regulatory submission documentation is complete and accurate
- Assist in drafting R&D and QC protocols and study reports
- Communicate findings and issues to Microbiology leadership
Key requirements- Extensive microbiological analysis skills with minimal guidance
- Strong knowledge of microbiological processes and testing
- Proficiency in LIMS and MODA
- Ability to work in aseptic environments (ISO 5) and enter cleanrooms
- Experience with cGMP environments and regulatory documentation
- Effective written and verbal communication, organization, and problem solving
- Capability to manage multiple tasks and maintain timelines
- Experience with reporting, trend analysis, and development summaries
- Bachelor-level degree in Microbiology or Biological Sciences; 3-5 years in a cGMP setting preferred
- strong communication
- multi-tasking
- problem solving
- gram stain
- endotoxin testing
- turbidimetric endotoxin testing
