Job Description

The Biotech Laboratory Specialist will ensure that all activities within the department align with current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). This role is critical for managing and performing a range of laboratory techniques, including PCR, ELISA, Capillary Electrophoresis, Isoelectric Focusing, Western Blotting, and Flow Cytometry. The specialist will also be responsible for preparing and executing method validation protocols and reviewing routine analysis reports. Experience with Quality Management Systems (QMS), particularly LIMS and EQMS, is essential. Key Responsibilities: Laboratory Techniques: Perform Polymerase Chain Reaction (PCR) assays for molecular analysis. Conduct Enzyme-Linked Immunosorbent Assay (ELISA) tests for biochemical assays. Operate and maintain Capillary Electrophoresis and Isoelectric Focusing systems. Execute Western Blotting and Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE) techniques for protein analysis. Perform Flow Cytometry for cell analysis and sorting. Conduct other biochemical and molecular biology tests as required. Method Validation: Develop and prepare method validation protocols to meet regulatory and internal standards. Execute validation procedures in accordance with regulatory guidelines and company practices. Accurately document and report validation results in a timely and comprehensive manner. Report Review: Review routine analysis reports to ensure accuracy, compliance with quality standards, and adherence to regulatory requirements. Identify and investigate any discrepancies or deviations in data, ensuring proper corrective actions are taken. Quality Management Systems: Maintain and manage Laboratory Information Management Systems (LIMS) for effective sample tracking and data management. Support and contribute to the Electronic Quality Management Systems (EQMS) to enhance and maintain laboratory quality processes. Ensure compliance with internal quality standards and regulatory guidelines at all times. Experience & Qualifications: Experience: 4-5 years of hands-on laboratory experience in a biotech or pharmaceutical setting. Education: Masters degree in Biotechnology or a related field. Key Skills: Expertise in PCR, ELISA, Capillary Electrophoresis, Isoelectric Focusing, Western Blotting, SDS-PAGE, and Flow Cytometry. Strong understanding of method validation and documentation. Familiarity with LIMS and EQMS systems. Knowledge of cGMP and cGLP requirements. Excellent attention to detail and strong problem-solving abilities. Work Schedule: Flexibility to work in 1st , 2nd , and General shifts as required. Additional Requirements: A proactive approach to quality and compliance, with a commitment to improving lab efficiency and accuracy. Ability to handle multiple tasks and meet deadlines in a dynamic, fast-paced environment.