Manufacturing Associate I -Cell Based Manufacturing

Responsibilities

• Reagent and Media Preparation
• Accurately retrieve, weigh, measure, mix, formulate, and filter raw materials, reagents, buffers, supplements, and cell culture media according to approved procedures.
• Verify formulation accuracy, lot information, labeling, and documentation prior to release or further use.
• Maintain proper handling, storage, and traceability of raw materials, intermediates, and finished components.
• Cell Culture, Expansion, and Banking
• Perform routine mammalian cell culture activities, including cell thawing, feeding, passaging, subculturing, expansion, counting, and cryopreservation.
• Support the generation and maintenance of Master Cell Banks and Working Cell Banks.
• Monitor cell growth, morphology, viability, and recovery following established procedures.
• Maintain accurate cell bank inventory records and ensure proper storage and traceability.
• Quality Control Testing
• Perform QC testing of cell culture media, reagents, and cell lines, including viability testing, growth curve analysis, sterility testing, and mycoplasma screening.
• Document QC results accurately and promptly in accordance with internal quality system requirements.
• Communicate any unexpected results, deviations, or potential quality concerns to the supervisor or quality representative.
• Documentation and Compliance
• Complete batch records, worksheets, forms, labels, and electronic records accurately, clearly, and in a timely manner.
• Follow approved SOPs, work instructions, and ISO 9001:2015 quality system requirements.
• Support documentation accuracy, product traceability, and change control expectations as applicable.
• Labeling, Packaging, and Inventory
• Dispense, label, and package final products and components with attention to accuracy, consistency, and traceability.
• Use Labguru ELN software to track material usage, manage raw material and cell bank inventory, and support restocking activities.
• Assist with routine inventory checks and communicate supply needs to support production continuity.
• Laboratory Organization and Safety
• Maintain a clean, organized, and safe work area in accordance with 5S principles, laboratory safety procedures, and PPE requirements.
• Properly handle biological materials, chemicals, and laboratory equipment according to established safety practices.
• Support routine cleaning, equipment preparation, and general laboratory readiness.
• Process and Cross-Functional Support
• Assist with process development, troubleshooting, optimization, and scale-up activities for new or existing reagent and cell-based manufacturing processes.
• Collaborate with QC, QA, R&D, and other internal teams to support product quality, process transfer, and production goals.
• Perform other duties as assigned to support department and company objectives.

  Qualifications

  • Bachelor’s degree in Biology, Chemistry, Biochemistry, Cell Biology, Biotechnology, or a related scientific discipline.
  • 0–2 years of experience in a laboratory, manufacturing, cell culture, reagent production, or assay production environment.
  • Basic understanding of aseptic technique and laboratory safety practices.
  • Ability to follow written procedures, accurately complete documentation, and maintain strong attention to detail.
  • Strong organizational, communication, and teamwork skills.
  • Ability to manage multiple tasks and adapt to changing production priorities.
  • Comfortable working with biological materials, cell culture media, reagents, and standard laboratory equipment.

  Preferred Qualifications

  • Hands-on experience with mammalian cell culture, including media preparation, cell line maintenance, expansion, and cryopreservation.
  • Experience with cell counting & viability assessment, sterility testing, mycoplasma testing, or growth curve analysis.
  • Experience working in an ISO 9001, GMP, GLP, or other regulated quality system environment.
  • Familiarity with ERP systems, electronic lab notebooks, Labguru, or similar inventory/documentation platforms.
  • Prior experience in biotechnology, life sciences manufacturing, reagent production, or cell-based assay support.