Manufacturing Manager

Reports to

Associate Director, Drug Development & Production

CNSide Diagnostics, LLC, a subsidiary of Plus Therapeutics, Inc., develops and commercializes proprietary clinical diagnostic laboratory tests, such as CNSide, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide Cerebrospinal Fluid Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in cerebrospinal fluid, informing and improving the clinical management of patients.

The Company is in the early stages of commercializing CNSide in the U.S.

The Manufacturing Manager will lead CNSide’s day-to-day manufacturing operations for all assay-critical consumables, including reagents, antibody capture mixes, microfluidic chips, and Cee-Sure preservation tubes. This role is responsible for managing manufacturing execution, supervising Manufacturing Technicians, and ensuring that all materials are produced, tested, documented, and released in accordance with controlled, ISO-aligned procedures to support CLIA testing operations. This position is critical to establishing reliable manufacturing capacity, maintaining inventory readiness, ensuring inspection‑ready compliance and enabling the transition from ad‑hoc production to a scalable, capacity‑based manufacturing operation.

• Lead Manufacturing Technicians and oversee daily manufacturing activities.
• Plan production to meet demand and inventory targets (~5,000 channels/year)
• Ensure compliant batch manufacturing, testing, documentation, and lot release.
• Lead deviations, investigations, and CAPA.
• Own equipment readiness, maintenance, and calibration.
• Support cleanroom and manufacturing area readiness.
• Maintain SOPs, training, and ISO‑aligned manufacturing control.
• Manage inventory, safety stock, and material traceability.
• Coordinate with Testing Operations and R&D on demand and process changes.

• A bachelor’s degree in a scientific field like Biology, Chemistry, Biochemistry, Biotechnology, or a related area.
• 5 or more years of experience in regulated life sciences manufacturing, such as diagnostics, biotech, or consumables.
• Experience leading/managing manufacturing teams.
• GMP manufacturing experience preferred, including documentation, deviations, and lot release.
• Expertise in building manufacturing infrastructure, like SOPs, training, and equipment readiness.
• Knowledge of batch manufacturing, investigations (OOS/OOT), CAPA, and release controls.
• Oversight of equipment maintenance, calibration, inventory planning, and material traceability.
• Hands‑on, execution‑focused leader with strong organizational skills and attention to detail.

• Ability to work in regulated laboratory or manufacturing environments.
• Strong organizational, documentation, and communication skills.
• Comfortable working in cleanroom or controlled environments.
• Ability to manage priorities in a fast‑paced setting.

Plus Therapeutics, Inc. and CNSide Diagnostics, LLC are Equal Employment Opportunity employers and consider all qualified applicants without regard to any protected status.