Biotechnologist – Laboratory (GMP Operations)

Biotechnologist – Laboratory vacancy to support GMP-compliant laboratory and manufacturing operations. The role involves hands-on execution of laboratory and production activities, ensuring strict adherence to cGMP regulations, supporting process improvements, and maintaining a high state of inspection readiness. The ideal candidate will bring strong technical expertise in cell culture, and GMP documentation, along with the ability to mentor team members and collaborate cross-functionally.

Job Responsibilities

• Perform laboratory and manufacturing activities in Grade CNC, Grade D, and Grade C cleanroom environments, strictly following GMP and cGMP requirements on Biotechnologist – Laboratory.
• Act as a subject matter expert for standard operating procedures (SOPs), batch records, protocols, and other controlled GMP documentation.
• Take full ownership of deviations, non-conformances, and quality events, including leading investigations, conducting root cause analysis, and implementing CAPA (Corrective and Preventive Actions).
• Ensure the laboratory areas, and equipment are consistently maintained in a state of inspection readiness for internal audits and regulatory inspections.
• Operate and support processing equipment, ensuring safe, efficient, and compliant manufacturing operations.
• Support cell culture operations, including upstream processing, scale-up activities, technology transfer, and process validation.
• Mentor, coach, and train new team members on GMP practices, laboratory techniques, and operational procedures.
• Collaborate closely with Quality Assurance, Manufacturing, Engineering, Validation, and Regulatory teams to ensure seamless operations and compliance.
• Identify and implement continuous improvement initiatives to enhance process efficiency, reduce waste, and support a lean, flexible, and agile manufacturing environment.
• Maintain accurate, timely, and compliant documentation in accordance with data integrity and regulatory standards.

Job Requirements- Qualifications

• Bachelor’s or Master’s degree in Biotechnology, Biochemistry, Life Sciences, Microbiology, or a related discipline.
• Minimum 3+ years of industry experience in a GMP-regulated biopharmaceutical or biotechnology environment.
• Hands-on experience with processing equipment and laboratory operations.
• Strong knowledge of cell culture principles, techniques, scale-up processes, technology transfer, and process validation activities.
• Proven experience in coaching, mentoring, and training junior staff or new team members.
• Solid understanding of GMP, cGMP, SOPs, deviations, CAPA, and regulatory compliance.
• Ability to work independently and collaboratively in a fast-paced manufacturing or laboratory environment.
• Demonstrated self-motivation, adaptability, problem-solving skills, and a positive, proactive attitude.