Senior Manager, QC Raw Materials (Biotech)

TL;DR

Senior Manager, QC Raw Materials (Biotech): Oversee raw materials management program including inspection, sampling, testing at Allogene and external labs with an accent on GMP compliance, vendor qualification, and phase-appropriate specifications. Focus on strategy implementation, cross-functional collaboration, LIMS/SAP management, and regulatory support to ensure timely compliant operations.

Location: Onsite 5 days a week at manufacturing facility in Newark, CA. Candidates must be authorized to work in the U.S.

Salary: $150,000–$180,000 per year

Company

Clinical-stage biotechnology company pioneering allogeneic CAR T cell therapies for cancer and autoimmune diseases.

What you will do

• Lead overall strategy, planning, implementation, and operation of raw materials program for compliant inspection, sampling, and testing within TAT.
• Collaborate with QA, Process, and Analytical Development to create specifications and qualify vendors.
• Manage vendor qualification, external labs, QC analysts hiring/training, and RM review board.
• Oversee sample management in LIMS, SAP metadata, submission documents, and deviation investigations.
• Interact with auditors/inspectors and cross-functional stakeholders to meet milestones.

Requirements

• Bachelor’s in chemistry, biochemistry or related (advanced preferred) + 6+ years in biotech/pharma.
• Experience managing external labs/vendors, GMP/QC systems, raw materials regulations.
• Strong technical writing for protocols/reports/investigations; LIMS/SAP for RM management.
• Regulatory interactions, inspections, filings; deviation management.
• Excellent organization, prioritization, independent/team work, communication skills.

Culture & Benefits

• Collaborative environment with talented team in cancer immunotherapy.
• Competitive compensation including performance bonus, equity, health insurance.
• Generous time off with 2 annual holiday shutdowns and more.