Quality Control Specialist

Introduction to role

Are you driven to ensure cell therapy products meet the highest standards and reach patients without delay? Do you see yourself using rigorous analytical science to accelerate safe, effective treatments to those who need them most? Join our Quality Control team and take on a high-visibility role where your decisions and data will directly influence product release and stability strategies.

In this role, you will be a key contributor to advancing our cell therapy pipeline, owning analytical method qualification and executing critical testing that underpins lot release and in-process control. You will organize, analyze, and present results with clarity, ensuring the QC Analytical laboratory runs reliably and compliantly. Your expertise will be recognized across teams, and your voice will help shape how we deliver consistently high-quality outcomes for patients.

Accountabilities

• Release and Stability Testing: Perform flow cytometry, ELISA, cellular cytotoxicity, dPCR, and cell-based potency assays to enable timely release testing and stability monitoring of cell therapy products and in-process samples, ensuring data integrity and fit-for-purpose results.
• Analytical Method Lifecycle: Support analytical method development, qualification, and technical transfer from Analytical Development; design, execute, and document qualification activities to ensure robust, reproducible methods ready for routine use.
• Technical Leadership and SME Support: Serve as a subject matter expert in technical discussions, document reviews, and investigations; provide data-driven guidance that resolves issues quickly and prevents recurrence.
• Documentation and Compliance: Author and/or review analytical test results, analytical study data summaries and reports, analytical method qualification protocols and reports, and standard operating procedures, ensuring alignment with regulatory expectations and internal quality standards.
• Routine Operations Excellence: Support daily QC analytical activities, monitor lab performance, and ensure the laboratory operates as expected, including occasional off-hour or weekend technical support to meet lot release timelines.
• Mentoring and Knowledge Sharing: Mentor and train associate specialists, elevating team capability and building consistent analytical practice across the laboratory.
• Continuous Improvement and Broader Impact: Identify opportunities to streamline workflows, improve assay performance, and reduce cycle time; translate scientific insights into operational gains that enhance product quality and speed to patients.

Essential Skills/Experience

• Associate’s degree in biological sciences or related field with 4+ years of experience, Bachelor’s degree in biological sciences or related field with 2+ years of experience, or MS in biological sciences or related field with 0+ years of experience is required.
• Flexibility of occasionally working on weekends or holidays to support lot release testing.
• Demonstrated ability to take ownership, initiative, and self-accountability.
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.
• Attention to detail and quick learning/application of concepts and information.
• Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work in a self-guided manner with scientific/technical personnel.
• Well-versed in various analytical techniques Flow cytometry, qPCR, dPCR, cell-based potency and/or ELISA experience.

Desirable Skills/Experience

• 2+ years of relevant experience in the Pharmaceutical or Biotechnology industry.
• Experience in Cell or Gene Therapy.
• Well-versed in various analytical techniques such as Flow cytometry, qPCR, dPCR, cell-based potency and/or ELISA experience.