Molecular Diagnostic Manager

Location

Contract Type

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

Recruit better talent faster - on your own or with our support.

Job search tips from Fuzu

Selected articles on cover letters, CV structure, and interview preparation.