Molecular Diagnostic Manager

DUTIES AND RESPONSIBILITIES:

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

QUALIFICATIONS & EXPERIENCE

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