Quality Control Microbiologist
Sanaria is a Rockville, Maryland biotechnology company working on the world’s first whole sporozoite- based malaria vaccine. Sanaria has an exciting opportunity for an experience Quality Control Microbiologist to join a world-class team as the company conducts Phase III clinical trials and the vaccine moves toward licensure.. The Sr. QC Microbiologist is responsible for product contamination control and environmental microbiology. This position reports to the Senior Director of QC Microbiology.
QC Microbiologist Responsibilities:
- Responsible for the environmental monitoring (EM) program of Sanaria’s process critical utilities and manufacturing environment.
- Responsible for sterility testing of in-process and final product testing.
- Ensures completion of EM sampling and timely reporting of EM trends.
- Responsible for setting up automated environmental monitoring data collection and trending systems.
- Responsible for developing studies to evaluate microbiological quality attributes for Sanaria’s aseptic manufacturing of PfSPZ products.
- Responsible for routine maintenance of QC microbiology lab and equipment.
- Sanaria’s point-of-contact to contract testing labs responsible for microbiological assays for product release.
- Responsible for using technical QC microbiology proficiency and independent thought to develop new alternate methods for sterility testing of in-process and final product testing.
- Writes and executes new SOPs and validation protocols.
- Responsible for OOS investigations and CAPA execution for final product.
- Experience with setting up microbial identification systems, a plus.
QC Microbiologist Requirements:
- Bachelor’s degree with 6-7 years’ microbiology experience or master’s degree with 3-4 years microbiology experience in QC of biotechnology or pharmaceutical products. MT experience will also be considered.
- Strong microbiology skills with a focus on drug product contamination control and environmental microbiology. Candidates with aseptic process validation experience a plus. Knowledge in isolation and identification of molds, fungi, and bacteria from samples.
- A thorough knowledge and understanding of current Good Manufacturing Practices (cGMP).
- Must be a self-starter with the ability to work independently and use good judgment.
- Should be able to handle multiple priorities, proactive, results oriented, and have strong attention to detail.
- Strong communication and written skills are essential.
To apply, send resume and cover letter to careers(at)sanaria.com, subject line QC Microbiologist. Applicants must be eligible to work in the US for any employer. Visa sponsorship is not available. Sanaria is an equal opportunity employer.