Mohammad Ghalei

Managing a team of approximately 100 professionals across seven key areas: raw materials, finished and semi-finished products, microbiology, cleaning validation, stability (FUS), equipment, metrology, and analytical development.

Key Responsibilities:

• Supervision of laboratory operations and regulatory compliance

• CAPEX and OPEX budget management

• Supervision of OOS/OOT investigations and continuous improvement

• Management of deviations, CAPA plans, and QC laboratory discrepancy analyses

• R&D support in resolving quality issues

Laboratory Expertise:

• Physico-chemical and microbiological analyses

• Environmental microbiological monitoring of production areas

• Qualification and validation of laboratory equipment

• Analytical method development (HPLC for cleaning validation)

• Stability studies of marketed products

• Control of solid, liquid, and injectable dosage forms

Production of medical radioisotopes such as Lu-177 and Ac-225.

In this dual technical and managerial role, I utilized my project management skills for planning, risk management, and quality control.

Achievements:

• Development of industrial chromatographic methods for the separation and purification of medical radioisotopes

• Increase in overall yield

• Elimination of metallic impurities

• Development of chemical processes

• Implementation of GMP production

Responsible for projects related to the stabilization of radiopharmaceuticals and the study of radiation effects (radiolysis).

Key Projects:

1. FLASH Radiotherapy

Development of a double-stranded DNA electrochemical biosensor for the detection and quantification of reactive oxygen species (ROS) in preclinical studies.

2. Astatine-211 Therapeutic Radiopharmaceuticals

Identification of the origin of radiopharmaceutical instability due to auto-radiolysis during purification. Successful modification of the process to stabilize the final product.