Job Posting for Quality Control, Microbiologist Contract at Neogene Therapeutics
Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, preclinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.
We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.
Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.
Neogene is searching for a highly motivated QC Microbiologist Contractor who will be responsible for compendial and rapid microbiology laboratory methods, serves as the technical lead for evaluation, validation, and implementation of new microbiology methods and EM program. This individual will work closely with functional technical operation teams supporting the organizational vision. This role is based in Santa Monica, CA and reports to Director of Quality.
Author, review and execute SOPs, Protocols, Reports relating to GMP microbiology processes, test methods and related equipment maintenance Participate and support regulator audits
Implement, maintain, and oversee environmental monitoring program, personnel monitoring, trending and analysis
Oversight of microbiology programs such as growth promotion, bioburden, BacT/ALERT rapid sterility, compendial sterility, and endotoxin methods.
Conduct investigations regarding environmental monitoring (EM) action level excursions, and out of specifications (OOS) results for microbiological testing.
Oversee and perform the day-to-day activities related to Environmental Monitoring, product release testing, and contamination control.
Perform other related duties and responsibilities as assigned.
Master’s Degree in a related science plus 4 years of GXP experience in the biotech and/or pharmaceutical industry specific to microbial contamination and controls OR Bachelor’s Degree in a related science and 6 years of GXP experience in the biotech and/or pharmaceutical industry specific to microbial contamination and controls
Demonstrated knowledge of regulatory guidance and industry best practices
Strong knowledge and experience in several of the following areas of competency: aseptic processing, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.
Expert knowledge and understanding of Microbiology principles, theories, concepts and laboratory methodologies.
Must demonstrate effective organizational skills and ability to manage multiple projects.
Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.
Strong knowledge of aseptic manufacturing and EM processes
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.