Molecular Diagnostic Manager

DUTIES AND RESPONSIBILITIES:

• Lead daily production of molecular diagnostic
• Ensure strict compliance with GMP, ISO 13485, SOPs, and quality
• Supervise and train production staff; plan manpower
• Oversee batch production records, documentation, and CAPA
• Monitor equipment performance, calibration, and preventive
• Drive workflow optimization and continuous process
• Lead scale-up of production from pilot to commercial batches, ensuring reproducibility and regulatory
• Implement electronic batch records and LIMS integration for
• Support incoming, in-process, and final QC testing requirements for open systems and/or closed molecular
• Document all production activities in compliance with ISO 13485 and/or WHO TGS/TSS
• Participate in method validation, verification, and technology development and transfer
• Identify opportunities for process optimization and cost reduction without compromising reagent
• Ensure SOPs and batch records are in place and consistently
• Oversee design and execution of performance evaluation studies (analytical and clinical).
• Champion contamination control strategies (cleanroom zoning, environmental monitoring).
• Work closely with R&D, QA, QC, and regulatory teams to support new product
• Train junior production staff on GMP/ISO 13485-compliant molecular reagent production techniques and GMP principles.

QUALIFICATIONS & EXPERIENCE

• Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Biochemistry, or related field preferred.
• Minimum 5 years of hands-on experience in molecular diagnostic production in a GMP/ISO 13485-compliant manufacturing
• Minimum of 3 years’ leadership experience as a supervisor of molecular reagent production teams.
• Proven track record in scaling up molecular diagnostic reagent production, compliant with GMP/ISO 13485
• Minimum 5 years in molecular diagnostics manufacturing, with at least 4 years in GMP/ISO 13485-compliant manufacturing leadership