Upstream Manufacturing Associate I

CONTRACT: 6 month contract to start with the potential to extend and convert to full-time

For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.
Shifts available:2nd shift: 2pm-10pm3rd shift: 10pm-6am
MUST HAVES:Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience
Position OverviewThe Upstream Manufacturing Associate I provides support for upstream manufacturing activities within a cGMP environment.
Key ResponsibilitiesUpstream ProcessingPerform cell culture activities including vial thaw, seed train expansion, fed-batch and perfusion bioreactor operations.Oversee harvest and filtration operations.Monitor critical process parameters and implement corrective actions when required.Troubleshoot process and equipment issues to ensure uninterrupted operations.
In-Process TestingPerform and review manufacturing support testing utilizing:Cedex Cell AnalyzerBlood Gas Analyzer (BGA)OsmometerOther process monitoring equipment
Documentation & ComplianceAssist with preparation and revision of: Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and Manufacturing forms/templatesSupport deviation investigations, CAPAs, and change controls.Ensure ongoing inspection readiness and GMP compliance.Participate directly in regulatory and client audits.
Cross-Functional CoordinationCoordinate activities between Manufacturing, QA, QC, MSAT, Warehouse, Facilities, and Supply Chain teams.Support process validation, technology transfer, and commercial manufacturing initiatives.Drive continuous improvement and operational excellence projects.
QualificationsEducation & ExperienceBachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience.High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.
Required SkillsBasic understanding of biological manufacturing and cell culture processes.Ability to follow detailed instructions and procedures.Strong attention to detail and documentation practices.Effective communication and teamwork skills.Knowledge of cGMP requirements is preferred.
Preferred SkillsExperience with:Cell culture operationsShake flask cultivationBioreactor systemsBuffer and media preparationSingle-use technologiesAseptic processing
Physical RequirementsAbility to stand for extended periods. xzbcwsv Ability to bend, reach, and lift up to 50 pounds.Ability to work in cleanroom environments while wearing required PPE.