Manager, Laboratory Materials & Manufacturing

Predicine, Inc•Hayward, CA

1d•Onsite

About The Position

We’re looking for a manager or Senior Manager to lead Laboratory Materials & Manufacturing Operations for our CLIA/CAP-certified NGS laboratory. You’ll bring NGS reagent preparation and QC, laboratory supply chain and inventory, and sample collection kit manufacturing under one team. You’ll make sure every reagent and kit is prepared, inspected, documented, and available on schedule under GMP, ISO 13485, and CLIA/CAP quality systems. This is a high-visibility leadership role for someone who wants to build scalable operations that support growing test volumes, new assays, and companion diagnostic (CDx) commercialization. We’ll hire at the Manager or Senior Manager level depending on experience.

Requirements

Bachelor’s degree in molecular biology, biotechnology, biochemistry, biomedical engineering, supply chain, or a related field; advanced degree preferred
5+ years of experience in biotechnology, molecular diagnostics, regulated manufacturing, laboratory materials, or supply chain (Manager); 8+ years with people-management experience for Senior Manager
Working knowledge of NGS workflows, reagent QC, lot control, batch documentation, inventory planning, and supplier management
Experience with GMP / ISO 13485 quality systems; IVD or collection kit manufacturing experience preferred
Proficiency with LIMS, ERP, or inventory management systems and Microsoft Excel
Strong cross-functional leadership, analytical, and communication skills; comfortable in a fast-paced, growing lab environment
CLIA/CAP familiarity and experience supporting audits a plus

Responsibilities

Lead preparation, QC, labeling, storage, and distribution of NGS reagents and reagent kits, planned against laboratory demand and approved specifications
Oversee QC acceptance, lot control, traceability, and expiration dating; review records and release reagents for testing within delegated authority
Manage purchasing, receiving, inspection, inventory, and distribution of reagents, consumables, and manufacturing materials
Maintain reorder points, safety stock, and FIFO/FEFO controls to prevent stockouts, expiration, and waste
Partner with QA on supplier qualification and performance monitoring; manage lead times and supply continuity risks
Run sample collection kit manufacturing: scheduling, assembly, packaging, labeling, in-process inspection, finished-kit QC, and batch records
Manage nonconforming materials, deviations, CAPAs, change control, and process improvements
Support internal, client, supplier, and regulatory audits and drive timely closure of findings
Hire, train, and develop the team; maintain role qualifications, safety practices, and clear SOPs
Collaborate with Wet Lab, QA, R&D, Regulatory Affairs, Project Management, and Finance on demand planning; report KPIs and risks and implement contingency plans