Manager, Laboratory Materials & Manufacturing

Job Description

Job Description

Job Title: Manager / Senior Manager, Laboratory Materials & Manufacturing Operations – NGS Reagents, Supply Chain & Kit Manufacturing
Location: Hayward, CA (Onsite) | Full-time
Company: Predicine

Predicine is a Silicon Valley-based global precision medicine company pioneering liquid biopsy cancer diagnostics. Our breakthrough cell-free DNA and cell-free RNA technology enables minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and early cancer detection. We partner with top biopharma companies worldwide to advance biomarker-driven clinical trials — and our people are at the heart of that mission.

About the Role
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.

Key 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

Qualifications

• 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

Why Join Predicine

• Work at the forefront of precision medicine and cancer genomics
• Full benefits package: medical, dental, and vision insurance
• 401(k) retirement plan, PTO, and paid holidays
• Collaborative, mission-driven team environment focused on improving patient outcomes
• Opportunities for professional growth within a growing biotech/diagnostics company

Equal Opportunity Employer
Predicine is proud to be an Equal Opportunity Employer, committed to a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability, or any other legally protected status. Qualified applicants will also be considered regardless of criminal history, consistent with applicable law. All information will be kept confidential according to EEO guidelines.

Compensation is based on qualifications, location, internal equity, and market data. All offers are contingent upon successful background verification. Applicants must be legally authorized to work in the USA.

We are not accepting third-party or agency resumes.