An innovative Medical Device company founded in Israel is developing a breakthrough nanotechnology-based platform for the treatment of advanced metastatic cancer. The company is seeking an experienced, hands-on Manufacturing Site Manager to establish and lead its U.S. nanoparticle manufacturing operation in Maryland. The U.S. manufacturing organization will include QA manager and 4-6 clean room operators/technicians. This is a greenfield manufacturing leadership role with end-to-end responsibility for building the site, establishing cleanroom operations, transferring and scaling manufacturing processes, building the team, and ensuring FDA/ISO compliance.

Job Responsibilities

• Lead the establishment and operationalization of the U.S. manufacturing site from the ground up.
• Build, recruit and lead the U.S. manufacturing team.
• Manage the ongoing operation of the ISO 5 aseptic filling room and ISO 7 chemical production cleanrooms.
• Lead the setup, commissioning and qualification of cleanrooms and manufacturing infrastructure.
• Establish and manage nanoparticle manufacturing processes, including tech transfer, and validation.
• Own day-to-day production, capacity, yield, quality and operational performance, including shipping the final product to US medical centers.
• Ensure compliance with FDA, cGMP and applicable ISO standards, including ISO 14644 and ISO QMSR/ISO 13485.
• Establish and manage SOPs, batch records, deviations, CAPA, change control, IQ/OQ/PQ and process validation.
• Work closely with QA/RA, Engineering, R&D and Supply Chain in both the U.S. and Israel.
• Prepare and maintain the site for FDA, ISO and customer audits/inspections.
• Drive continuous operational excellence and manufacturing scalability.
• Coordinate with local subcontractors and service providers for calibration and maintenance of the cleanroom and its equipment.

Requirements

• BSc/MSc in Chemical Engineering, Chemistry, Materials Science, Biotechnology, Pharmaceutical Sciences or related fields.
• 7–12+ years of manufacturing experience in Pharma, Biotech, Medical Device, Specialty Chemicals or Advanced Materials.
• Proven experience in managing cleanroom manufacturing facilities – mandatory.
• Hands-on experience in FDA- and ISO-regulated environments – mandatory.
• Strong knowledge of cGMP, ISO 14644, ISO 13485, validation and quality systems.
• Experience with IQ/OQ/PQ, process validation, CAPA, deviations and change control.
• Proven experience in process scale-up and technology transfer from R&D to manufacturing.
• Demonstrated ability to build and lead a manufacturing team and operation from the ground up.
• Experience with nanoparticles/nanomaterials or complex chemical manufacturing – a strong advantage.
• Hands on learner with high integrity, problem-solving skills, and leadership skills.

Salary Range: TBD

Vacancy Type: Full Time

Location: Maryland

Closing Date: Employer is ready to hire ASAP!

Job ID: 70117MSM