Senior Analyst, QC Analytical

Responsibilities

• Perform and review QC analytical testing to support product release, stability, and in-process control for advanced immunotherapy products.
• Conduct bioanalytical testing using methods such as ELISA, digital droplet PCR (ddPCR), flow-based assays, flow cytometry, and cell-based assays, ensuring accuracy, precision, and compliance with approved methods.
• Review QC data and documentation for completeness, accuracy, and adherence to SOPs, methods, and regulatory expectations.
• Execute sample management activities including sample receipt, verification, aliquoting, labeling, storage, and maintaining sample chain of custody for manufacturing and QC testing.
• Collaborate closely with the Analytical Development team to perform testing in support of method qualification and transfer activities.
• Provide QC input and perspective during method troubleshooting and optimization, partnering with cross-functional teams to resolve technical issues.
• Support stability programs by coordinating and performing stability timepoint pulls and associated testing according to established protocols.
• Participate in Operational Excellence and Continuous Improvement initiatives, applying OE/CI philosophies and tools in a regulated laboratory environment to enhance efficiency and quality.
• Independently own and complete daily laboratory tasks such as inventory management, critical reagent qualification, cell passaging, and general bench work.
• Support QC microbiology activities as needed, including execution of microbiology assays and compendial methods, and application of aseptic techniques.
• Ensure all work follows approved documents, including SOPs, test methods, protocols, and relevant regulatory guidance, and promptly escalate deviations or issues.
• Maintain laboratory readiness by supporting equipment use, basic maintenance, and documentation in shared lab spaces.
• Contribute to the development and maintenance of quality systems and laboratory startup activities as applicable.
• Work effectively within a shared resource “One QC” model, supporting both QC analytical and microbiology functions based on operational needs.
• Communicate clearly with team members, raise questions during training, and proactively seek clarification to ensure full understanding of procedures.
• Identify opportunities for process improvements, suggest enhancements to workflows and assays, and actively participate in implementing better ways of working.
• Balance independent work with collaborative scheduling in a pull-based system, self-scheduling tasks to meet team and project priorities.
• Uphold a strong culture of safety by correctly using personal protective equipment, following cleanroom and laboratory procedures, and maintaining a safe work environment.

Qualifications

• Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or another life science discipline, or an equivalent combination of advanced education and experience.
• 3–5 years of experience in a cGMP-regulated QC environment at a Senior analyst level.
• Demonstrated quality control experience in a cGMP laboratory setting.
• Molecular biology background with hands-on experience in digital PCR (including ddPCR), ELISA, flow cytometry, and cell-based assays.
• Proficiency in executing laboratory work according to approved SOPs, test methods, protocols, and related documentation.
• Basic knowledge of relevant pharmaceutical regulations and regulatory guidance applicable to QC laboratories.
• Experience performing bioanalytical testing such as ELISA, flow-based assays, and ddPCR in a regulated environment.
• Experience managing sample handling workflows including sample receipt, aliquoting, storage, and chain-of-custody documentation.
• Familiarity with compendial assays and general analytical techniques.
• Ability to gown aseptically and work in a cleanroom environment in compliance with aseptic practices.
• Ability to wear personal protective equipment, including gloves, protective clothing, and eye protection, for extended periods.
• Physical ability to work around laboratories and manufacturing areas and regularly lift up to 20 pounds.
• Capability to work independently while contributing effectively as part of a team in a shared resource model.
• Strong communication skills with the confidence to ask questions, speak up when something is unclear, and actively participate in training.
• Demonstrated passion for teamwork, commitment to shared purpose, and support for a positive, inclusive workplace culture.