Quality Control, Microbiology Specialist
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating.
The QC Specialist, Microbiology will primarily be responsible for design and implementation of an Environmental Monitoring Program and to perform routine in process and final release microbial testing of immunotherapy products in a new GMP manufacturing facility. This role will require a technical background in microbiology and a demonstrated ability to establish robust microbial programs in a regulated cGMP environment.
This role will serve as a microbial programs subject matter expert for the site as well as partner closely with the Manufacturing, Quality Assurance and Analytical Development teams to develop robust microbial programs and methods.
- Assist in build-out of the QC labs by assisting and providing technical expertise in the selection, purchase and installation of microbial QC equipment
- Actively engage with Manufacturing and Quality Assurance to establish robust programs for Environmental Monitoring Program (total air particulate, viable air, surfaces and personnel) and Aseptic Process Simulation in an ISO environment
- Generation of microbial test methods and supporting Standard Operating Procedures (SOPs) that comply with cGMP, USP, EP, ICH, FDA regulatory requirements
- Create and execute protocols for the transfer and validation of QC Release test methods for viral vector and drug product
- Execute test method transfer, qualification, troubleshooting and validation
- Routine release testing for viral vector and drug product, including sterility, endotoxin
- Perform routine Environmental monitoring, sterility testing, bioburden and growth promotion
- Provide input for training programs for manufacturing staff and QC Microbial staff
- Report regularly on alerts, actions, trends and out of specification results within the facility
- Maintain critical reagents inventory and qualification for QC labs
- Performing routine maintenance on QC equipment
- Monitor compendia to ensure that processes are current with industry standards
- Work effectively in a team environment as well as contributing to meet project timelines and deliverables
- Identify opportunities for operational excellence, application of Lean principles and continuous improvement
- A minimum of 6 years of microbial testing within an FDA/EMA regulated cGMP environment
- Knowledge of industry guidelines for ICH, USP, FDA and EP
- Demonstrated experience developing Environmental Monitoring and Aseptic Stimulation programs in a GMP manufacturing facility
- Experience with implementation of sterility testing method in a GMP environment. Bac-T experience is a plus
- Bachelor’s or master’s degree in a relevant field (e.g. Immunology, Cell Biology) is preferred
- Must have excellent oral and written communication skills
- Ability to work independently and collaboratively among cross-functional teams
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
- Excellent analytical skills and scientific/technical expertise
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.