Senior Manager, Lab Materials & NGS Reagents Ops

Predicine; Hayward (CA); Sur place; USD 130 000 - 190 000; Plein temps

Avantages offerts par ce poste

Full benefits package

401(k) retirement plan

PTO and paid holidays

Collaborative, mission-driven team

Résumé du poste

Predicine, a Silicon Valley-based precision medicine company, seeks a Manager or Senior Manager to lead Laboratory Materials & Manufacturing Operations for its CLIA/CAP-certified NGS lab in Hayward, CA. You will oversee reagent prep, QC, inventory, and kit manufacturing under GMP/ISO 13485 and CLIA/CAP quality systems to support growing test volumes and new assays.

Join a fast-paced, growth-focused biotech environment where you’ll build scalable operations, manage a diverse team, and partner

Qualifications

• Bachelor’s degree in molecular biology, biotechnology, biochemistry, biomedical engineering, supply chain, or related field.
• 5+ years in biotech, molecular diagnostics, regulated manufacturing, or supply chain (Manager); 8+ years with people management for Senior Manager.
• Experience with GMP/ISO 13485 quality systems; IVD or kit manufacturing experience preferred.
• Proficiency with LIMS, ERP, or inventory management systems and Excel.
• Strong cross-functional leadership and communication in a fast-paced lab.

Responsabilités

• Lead preparation, QC, labeling, storage, and distribution of NGS reagents and reagent kits.
• Oversee QC acceptance, lot control, traceability, and expiration dating; release reagents for testing.
• Manage purchasing, receiving, inspection, inventory, and distribution of reagents and materials.
• Maintain reorder points, safety stock, and FIFO/FEFO controls.
• Partner with QA on supplier qualification and performance monitoring; manage lead times.
• Run kit manufacturing: scheduling, assembly, labeling, QC, and batch records.
• Manage nonconforming materials, deviations, CAPAs, change control, and improvements.
• Support audits and drive timely closure of findings.
• Hire, train, and develop the team; maintain SOPs.
• Collaborate on demand planning; report KPIs and risks.

Connaissances

Leadership

GMP/ISO knowledge

Inventory management

NGS workflows

Excel

Communication

Formation

Bachelor’s degree in molecular biology or related field

Advanced degree preferred

Outils

LIMS

ERP systems

Microsoft Excel

Inventory management systems

Description du poste

Predicine, a Silicon Valley-based precision medicine company, seeks a Manager or Senior Manager to lead Laboratory Materials & Manufacturing Operations for its CLIA/CAP-certified NGS lab in Hayward, CA. You will oversee reagent prep, QC, inventory, and kit manufacturing under GMP/ISO 13485 and CLIA/CAP quality systems to support growing test volumes and new assays.

Join a fast-paced, growth-focused biotech environment where you’ll build scalable operations, manage a diverse team, and partner