Quality Control Analyst II (24012-B-682-QC)

ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Quality Control Analyst II to work onsite based in our Hayward office. ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. With our programmable and computationally driven approach, our team is engineering living medicines to attack cancer’s inherent multi-faceted nature and overcome the challenges of addressing solid tumors with cell therapy. Driven by a collective of diverse experts across immunology, synthetic biology, molecular biology, automation and computational biology, we are united in purpose to deliver radical breakthroughs for people with cancer, and prioritize the team’s outcomes over individual goals to achieve our company mission – together. We are seeking a talented and motivated QC Analyst to join the ArsenalBio Technical Operations Quality team. The individual will perform analytical QC testing for clinical-phase cell therapy products within the ArsenalBio GMP QC organization. The individual will work closely with Quality Operations, Process Development, Analytical Development, and Manufacturing to enable the success of ArsenalBio’s clinical scale manufacturing process. This position will report to the Head of Quality Control.

What You Will Do:

• With minimal guidance and support from senior team members, performs routine and non-routine testing for in-process, intermediates, final product, and stability samples
• Compile and review QC data to ensure accuracy and regulatory compliance and provide summaries to management as needed
• Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Assist in the development, revision, application, maintenance, and validation of SOPs
• Assist with the completion of deviations, OOS, change control, investigations, and CAPA
• Apply knowledge to troubleshoot assay and equipment problems
• Provide additional support to other functions, as requested by management, to support project milestones
• Participates in laboratory organization activities (instrument maintenance, cleaning, organizing, re-stocking materials) as needed
• Performs reagent and media preparation
• Position will require travel between manufacturing and testing locations in the San Francisco Bay Area, including San Francisco and Hayward

What Will You Bring:

• Bachelor’s degree or advanced degree in relevant scientific field or discipline
• 2+ years of experience in biotechnology/pharmaceutical industry
• Prior experience in QC analytical lab,  general lab techniques like cell counting, cell culture, Endotoxin etc.
• Knowledge and understanding of cGMP, GDP, and ICH regulations
• Ability to follow SOPs and lab organization is required
• Strong written and verbal communication skills
• Ability to work in GMP laboratory environments
• Self-motivated, technically driven, and willing to take on duties out-side of general responsibilities

What We Will Offer You:An opportunity to work with the best talent in the field of cell therapy, and be part of ONE TEAM to advance therapies to patients who need it most. ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge. We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now. We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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