Specialist, Quality Control, Bioassay
hace 2 días
Moderna – Madrid, Community of Madrid, SpainJoin Moderna, a pioneering team revolutionizing medicine through mRNA technology with a diverse pipeline across various diseases.As a key contributor in our Madrid site, you will support the QC Bioassay team, executing routine cGMP analytical testing for product release and stability programs, and providing method support, development, and laboratory investigations.The RoleModerna’s commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career with the potential to impact patients worldwide. Your role will involve analytical bioassay testing (qPCR, electrophoresis, sequencing) in a cGMP environment, method support, sample testing, LIMS usage, SOP creation, and participation in quality system records.Key ResponsibilitiesPerform analytical bioassay testing including qPCR, electrophoresis, and sequencing in a cGMP environment.Support method transfers and method development activities aligned with QC standards.Conduct routine sample testing for release and stability, maintaining full regulatory compliance.Utilize LIMS (LabVantage) for result entry and execute Electronic Assay Forms.Write and revise SOPs, protocols, and technical reports as needed.Complete cGMP documentation according to Good Documentation Practices.Participate in authoring quality system records such as deviations, investigations, change controls, and CAPAs.Maintain audit‑ready laboratory records and documentation.Establish and uphold a safe working laboratory environment.Additional ResponsibilitiesPerform general lab activities such as reagent preparation, equipment maintenance, sample management, and housekeeping.Support junior colleagues with training, troubleshooting, and method familiarization.Manage inventory and QC laboratory supplies.Assist with equipment and assay troubleshooting.Contribute to data trending and special projects.Participate in lab digitalization initiatives with AI‑enabled tools.Required Mindsets and SkillsRapid learner; ability to master evolving QC technologies and methods.Embrace digital solutions, working with LIMS, laboratory informatics, and AI‑enabled tools.Collaborate effectively in a cross‑functional matrix environment.Prioritise and complete multiple projects in a fast‑paced setting.QualificationsBA/BS in Biology or related scientific discipline (preferred). 2–5 years of experience in a pharmaceutical QC laboratory.Hands‑on experience with sequencing, qPCR, electrophoresis, etc.Knowledge of FDA, EU, ICH guidelines and regulations.Site‑based; full‑time at Moderna’s Madrid location (remote not permitted).BenefitsQuality healthcare and insurance benefits.Lifestyle Spending Accounts.Free premium access to fitness, nutrition, and mindfulness classes.Family planning and adoption benefits.Generous paid time off, vacation, bank holidays, volunteer days, sabbatical, global recharge days, discretionary year‑end shutdown.Savings and investments.Location‑specific perks.About ModernaSince 2010, Moderna has built a leading mRNA technology platform, reimagining medicine delivery and creating a world‑class team. We believe in giving people a platform to change medicine and the world.Equity, Diversity & InclusionModerna is a smoke‑free, alcohol‑free, and drug‑free work environment. We are committed to equal opportunity and non‑discrimination for all employees and qualified applicants, including reasonable accommodation for disabilities. #J-18808-Ljbffr
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Senior QC Bioassay Specialist
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Madrid, España Moderna A tiempo completoA leading biopharmaceutical company in Madrid is seeking a Senior Specialist, Quality Control, Bioassay. This role involves performing QC Bioassay testing, reviewing analytical data, and ensuring compliance with cGMP standards. Ideal candidates will have at least 4 years of experience in mammalian cell work and a BA/BS in a scientific discipline. Benefits...
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