Job Description
Job Summary
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The Manufacturing Associate will support the manufacturing of viral vector products in a cGMP-regulated environment. Under supervision, this role will execute manufacturing activities in accordance with approved batch records, SOPs, safety requirements, and Good Documentation Practices (GDP). The position requires strong attention to detail, proper aseptic technique, and the ability to consistently follow established manufacturing procedures.
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Key Responsibilities
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- Execute manufacturing activities in compliance with batch records, SOPs, cGMP regulations, and site safety requirements.
- Perform Chromatography and Ultrafiltration/Diafiltration (UF/DF) operations for viral vector manufacturing under supervision.
- Follow proper aseptic technique, cleanroom etiquette, and contamination-control practices.
- Accurately complete manufacturing documentation in accordance with Good Documentation Practices (GDP).
- Perform raw material weighing and dispensing according to approved procedures.
- Complete electronic inventory transactions using Manufacturing Execution Systems (MES) and Enterprise Business System (EBS).
- Prepare, assemble, and operate single-use systems supporting buffer preparation and manufacturing processes.
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Qualifications
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- Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemistry, Pharmaceutical Sciences, or a related field, or equivalent relevant experience.
- Experience in a cGMP manufacturing environment, preferably within biopharmaceutical or viral vector manufacturing.
- Knowledge of batch records, SOPs, cGMP regulations, GDP, and aseptic processing.
- Experience with Chromatography, UF/DF, buffer preparation, or single-use systems is preferred.
- Familiarity with MES and EBS or similar electronic manufacturing/inventory systems is a plus.
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