Senior Analyst, Analytical and Quality Control

Responsibilities:

• Perform and/or support QC testing activities for samples generated for release testing and compliance of cell therapies destined for human clinical trials, as well as materials used in their production, with a focus on flow cytometry & cell-based assays.
• Support process implementation for sample receipt, and in-process and release testing of raw materials, cell lines, process intermediates, drug products and other materials.
• Support cell based and molecular testing, as needed.
• Liaise with CROs for sample submissions and external testing results reporting.
• Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
• Perform instrument maintenance, antibody titrations, liaise with external instrument service representatives as needed.
• Write, review and drive approval of SOPs related to quality control testing including test methods, equipment operation and maintenance procedures.
• Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies.
• Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory and reagent preparation.
• Support QA and QC functions for cleanroom operations, including review and tracking of Environmental Monitoring data and cleanroom maintenance practices.
• Other duties as required.
• Minimum Requirements:
• BSc in Life Sciences with minimum 5 years relevant experience in Cell Biology, Genetics, Biotechnology, Biochemistry or related field. MSc with minimum 3-year relevant experience preferred.
• Strong preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment.
• Experience in flow cytometry based assays is required.
• One or more of the following techniques is preferred: qPCR/ddPCR, Pluripotent Stem cell culture, Fluorescence microscopy, High throughput imaging, Next generation sequencing, ELISA, HPLC.
• Experience in the following areas is highly desirable: cell therapy, pluripotent stem cells, gene editing, biotech.
• Excellent written and oral communication skills, with keen attention to detail and highly organized.
• Demonstrated flexibility in adjusting to changing priorities and schedules.
• Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus.
• Flexibility to work off-hours, and weekends on an as-needed basis is required.
• Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
• We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.