Quality Control, Flow-Cytometry/Cell-Based Assays 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 Flow Cell Specialist will primarily be responsible for establishment of QC release testing of immunotherapy products at a GMP facility, with a focus on flow-cytometry and cell-based test methods. This role will require a technical background in either or both of these areas in a regulated cGMP environment.
This role will serve as a key member of the QC team as well as partnering closely with the Analytical Development (AD) and Manufacturing teams for testing and releasing drug product.
- Assist in build-out of the QC labs by assisting and providing technical expertise in the selection, purchase and installation of QC equipment
- Work cross-functionally with AD in the assessment of the suitability of methods for the QC release testing
- Participate in authorship and review of GMP test methods and supporting Standard Operating Procedures (SOPs) for the manufacturing site
- Collaborate in the design of protocols for the co-qualification and transfer of QC Release test methods for viral vector and drug product
- Execute test method transfer and qualification
- Performance of routine release testing for viral vector and drug product
- Maintain critical reagents inventory and qualification for QC labs
- Performing routine maintenance on QC equipment
- 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 flow-cytometry testing within a regulated cGMP environment. Cell-based assay experience is a plus.
- Quality systems experience in managing deviations, CAPAs and change controls
- Experience with technical role within a GMP biopharmaceutical manufacturing operation
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
- Effectively prioritize and balance competing priorities
- Strong analytical and communication skills
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.