This Facility Manager ensures that all processes and systems related to drug product release remain in a validated state, adhering to current Good Manufacturing Practices (cGMP). Oversee environmental monitoring, facility control, and equipment management to maintain compliance with corporate and regulatory standards. Execute validation activities and oversee environmental monitoring according to documented risk assessments and ISO classification levels. Manage day-to-day facility operations, including gowning and material transfer training for GMP personnel. Serve as the primary point of contact for integrated facility maintenance, ensuring cleanroom and supporting areas meet GMP aseptic operational standards. Manage equipment qualification, calibration, and preventive maintenance programs to maintain regulatory compliance. Collect, analyze, and trend environmental and utility sampling data, taking appropriate action to address deviations. Prepare and present facility compliance reports to internal and external stakeholders.

Directs daily laboratory operations of a division, department, function, or program. Conducts and manages quality assurance and quality control and instructs staff on quality control and analytical procedures. Develops complex design projects and laboratory procedures and evaluates new products. Writes grant applications and manuscripts independently. Ensures compliance with all applicable regulations.

Directs daily laboratory operations of a division, department, function, or program. Conducts and manages quality assurance and quality control and instructs staff on quality control and analytical procedures. Develops complex design projects and laboratory procedures and evaluates new products. Writes grant applications and manuscripts independently. Ensures compliance with all applicable regulations.

This Facility Manager ensures that all processes and systems related to drug product release remain in a validated state, adhering to current Good Manufacturing Practices (cGMP). Oversee environmental monitoring, facility control, and equipment management to maintain compliance with corporate and regulatory standards. Execute validation activities and oversee environmental monitoring according to documented risk assessments and ISO classification levels. Manage day-to-day facility operations, including gowning and material transfer training for GMP personnel. Serve as the primary point of contact for integrated facility maintenance, ensuring cleanroom and supporting areas meet GMP aseptic operational standards. Manage equipment qualification, calibration, and preventive maintenance programs to maintain regulatory compliance. Collect, analyze, and trend environmental and utility sampling data, taking appropriate action to address deviations. Prepare and present facility compliance reports to internal and external stakeholders.