Associate, Quality Control Microbiology - Neogene Therapeutics

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

We are looking for someone with cell therapy quality control background to join our Quality team. You will contribute to the advancement of our product pipeline by performing environmental monitoring, lot release testing and other assigned tasks. You will also independently organize, analyze results, and present conclusions. You will ensure that the QC Microbiology Laboratory is operating as expected. This role is based in Santa Monica, CA but will require travel to our Tarzana, CA location as well.

Responsibilities

• Conduct microbiological tests, including environmental monitoring, sterility testing by BACT and compendial, bioburden testing, endotoxin testing, and microbial identification. routine environmental monitoring (EM) in GMP manufacturing areas, Aseptic gowning, growth promotion tests and Mycoplasma Testing (qPCR method MycoSEQ).
• Complete Environmental Monitoring Performance Qualification (EMPQ) protocols.
• Ensure the QC microbiology laboratory is well-maintained, including equipment calibration, validation, and maintenance. Manage laboratory supplies and inventory.
• Interpret microbiological data, ensuring accuracy and compliance with established standards. Maintain detailed and accurate records of all testing and results. Participate in EM excursion and out of specification (OOS) investigations.
• Review QC Micro test results.
• Work with multiple teams, including Manufacturing, Quality Assurance, and R&D, to support ongoing projects and ensure quality standards are met.
• Perform other responsibilities as requested by supervisor/manager to support the quality team.

Education and Experience

• BS or MS in biological sciences or a related field is required.
• Experience in Cell or Gene Therapy
• Demonstrated knowledge of regulatory guidance and industry best practices
• Knowledge in several of the following areas of competency: aseptic processing, clean room gowning and contamination control, environmental monitoring. .
• Understanding of Microbiology principles, theories, concepts and laboratory methodologies.
• Must demonstrate effective organizational skills and ability to manage multiple projects.
• Must have demonstrated experience interpreting technical results and summarizing these results in technical reports.
• Knowledge of aseptic manufacturing and EM processes

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $50,967 to $63,709. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

• Short-term incentive bonus opportunity
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.