Biotech Company seeks a highly motivated, experienced microbiologist to support the product development & manufacturing process of rapid test kits for certain diseases.
Duties and Responsibilities
- Microbiological analysis of raw materials, in-process, and finished products according to standard operating procedures.
- Conduct research into the structure, function, ecology, biotechnology, and genetics of micro-organisms, including bacteria, fungi.
- Conduct research in biotechnology to discover, develop and refine, and evaluate new products
- Environmental monitoring of controlled manufacturing and laboratory areas including, data trending.
- With minimal supervision able to qualify and execute test methods according to internal quality policies and regulatory guidelines
- Develop regulatory programs
- Identify and initiate laboratory investigations as needed.
- Review laboratory test data, SOP’s, test procedures, method/equipment validation protocols, reports, and logbooks.
- Manage inventory needs for test materials and supplies.
- Experience with medical devices such as rapid testing for infectious diseases, blood infections, viral diseases
- Bachelor’s Degree in science or related discipline (biology or microbiology preferred)
- Three to five years of experience in a GMP environment (pharmaceutical microbiology lab experiences an asset)
- Thorough understanding of CGMP’s USP/EP/ISO and other regulatory requirements for laboratory operations
Job Types: Full-time, Permanent