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GMP Manufacturing Technician

Cube Hub Inc. - Frederick, MD

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Job Description

Job SummaryWe are seeking a highly motivated Cell Therapy Specialist to join a state-of-the-art commercial Cell Therapy Manufacturing team focused on innovative immunotherapy products aimed at curing cancer.The Cell Therapy Specialist will perform and verify manufacturing activities for commercial cell therapy products by following batch records, SOPs, and cGMP requirements. This role works closely with Manufacturing, Materials Management, Quality Control, and Quality Assurance teams to support compliant GMP production operations.Shift & Schedule InformationInitial training period: First 8-10 weeks, Monday-Friday, 7:30 AM - 4:00 PMDuring onboarding/training, employees follow the company holiday scheduleAfter training completion, contractors will transition to department-assigned shifts based on operational needsThis is a full-time 4/10 schedule role; shifts may change depending on department requirementsAvailable ShiftsDay Shift6:00 AM - 4:30 PMSun-Wed, Wed-Sat, or Thurs-SunSwing Shift3:00 PM - 1:30 AMSun-Wed, Wed-Sat, or Thurs-SunSwing Shift5:00 PM - 3:30 AMSun-Wed, Wed-Sat, or Thurs-SunImportant: Once deployed to shift, employees are considered essential personnel and may be required to work during company holidays and shutdown periods.Key ResponsibilitiesPerform and verify manufacturing operations according to batch records and SOPsTroubleshoot processing and equipment issues and escalate concerns to managementOperate, monitor, clean, and prepare automated cell processing, cell expansion, and filling equipmentWork within Grade B/C cleanroom environments following strict GMP gowning and PPE proceduresComplete required technical and cGMP compliance trainingAuthor and revise SOPs to support compliant and efficient manufacturing operationsSupport investigations, deviations, CAPAs, and change control activitiesIdentify opportunities for process improvements and manufacturing efficienciesCollaborate cross-functionally with Quality Assurance, Quality Control, and Materials teamsAbility to wear a respirator while using specific cleaning chemicalsRequired QualificationsEducation & ExperienceCandidates must meet one of the following:Bachelor's Degree in a Life Sciences fieldAssociate's Degree in a Life Sciences field with 1+ years of biotech experienceHigh School Diploma with 2+ years of cGMP manufacturing experiencePreferred SkillscGMP manufacturing experienceCleanroom operations knowledgeSOP authoring and revision experienceEquipment troubleshooting skillsBiotech or pharmaceutical manufacturing backgroundStrong documentation practicesAbility to work in fast-paced manufacturing environmentsTeam collaboration and communication skillsTop 5 Must-Have SkillscGMP Manufacturing ExperienceCleanroom/GMP Environment ExperienceSOP & Batch Record DocumentationEquipment Troubleshooting SkillsBiotech or Cell Therapy Manufacturing BackgroundIf interested, please send a copy of your resume in word format along with the following details ASAP or you can also refer your Friend. We have an excellent referral program that we offer, for details please visit: Full Name:Current Location:Email:Contact:Education Details:Hourly rate:Work Authorization GC or US citizen/ Visa Status:Total exp in yearsTop Must-Have SkillscGMP Manufacturing ExperienceCleanroom & Aseptic Processing ExperienceSOP & Batch Record DocumentationEquipment Operation & TroubleshootingBiotech/Cell Therapy Manufacturing KnowledgeGMP Compliance & Quality Systems Understanding

Created: 2026-05-15

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