Sr. Specialist, Quality Control, Bioassay (Cell-Based Methods)

Location: Madrid, Spain; 100% onsite

Company

hirify.global develops mRNA technology and supports a global manufacturing network and medicine pipeline.

What you will do

• Perform cGMP data review for QC Bioassay testing, focusing on cell-based methods used for release and stability programs.
• Lead or support laboratory investigations, OOS/OOT assessments, deviations, CAPAs, change controls, root cause analysis, and corrective actions.
• Provide technical expertise for mammalian cell assays, including troubleshooting methods, equipment, and laboratory systems.
• Support method transfers, qualifications, acquisitions, validations, lifecycle activities, and stability data trending.
• Review, author, and approve controlled GMP documentation, including SOPs, protocols, reports, and release documentation.
• Collaborate with QC, QA, Manufacturing, Technical Development, Digital, and other functions while providing technical guidance to junior colleagues.

Requirements

• BA/BS in a scientific discipline, or an MS in a relevant scientific discipline.
• More than 4 years of experience focused on mammalian cells, or 2 years with a relevant MS.
• Experience with cell-based ELISA and in vitro potency assays.
• Working experience in a GMP environment and knowledge of FDA, EU, and ICH guidelines are preferred.
• Ability to work effectively in a fast-paced, cross-functional environment and manage multiple priorities.
• Proficiency in English is required for global collaboration.

Nice to have

• Experience with Generative AI-enabled tools in scientific knowledge management, data review, trending, documentation, or laboratory efficiency.

Culture & Benefits

• In-person work model supporting direct collaboration, mentorship, and site-based laboratory operations.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, and family-building support.
• Paid time off including vacation, holidays, volunteer days, sabbatical, recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific benefits.