Senior Manager, NGS Materials & Kit Manufacturing

ADP, Inc.; Hayward (CA); Presencial; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

401(k) retirement plan

PTO and paid holidays

Career growth in biotech/diagnostics

Descripción de la vacante

Predicine is hiring a Manager/Senior Manager to lead Laboratory Materials & Manufacturing Operations for a CLIA/CAP-certified NGS lab in Hayward, CA. You will oversee reagent preparation, QC, inventory, and kit manufacturing under GMP/ISO 13485 quality systems, ensuring on-time delivery and compliance.

The role emphasizes scalable operations to support increasing test volumes, new assays, and CDx commercialization; management experience is required.

Formación

• 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.

Responsabilidades

• 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

Conocimientos

NGS workflows

Reagent QC

Lot control

Batch documentation

Inventory planning

Supplier management

Cross-functional leadership

Quality systems knowledge

Educación

Bachelor’s degree in life sciences

Advanced degree preferred

Herramientas

LIMS

ERP

Microsoft Excel

Descripción del empleo

Predicine is hiring a Manager/Senior Manager to lead Laboratory Materials & Manufacturing Operations for a CLIA/CAP-certified NGS lab in Hayward, CA. You will oversee reagent preparation, QC, inventory, and kit manufacturing under GMP/ISO 13485 quality systems, ensuring on-time delivery and compliance.

The role emphasizes scalable operations to support increasing test volumes, new assays, and CDx commercialization; management experience is required.