Christina Schwalbe

Qc Operations Lead (Contract Laboratory Organization) @Genentech

Oceanside, CA, US
EMAILS
s••••••••@gene.com
MOBILE NUMBERS
+17•••••••10

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WORK HISTORY

Feb 2025 — Present

Qc Operations Lead (Contract Laboratory Organization) @Genentech

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Oceanside, CA, US

EDUCATION

1993 — 1997

Whittier College

Bachelor's degree, Biology/Biological Sciences, General

SKILLS

MicrobiologyQuality SystemV&VProcess ImprovementManufacturingTechnology TransferLean ManufacturingCross-Functional Team LeadershipChange ControlIon ChromatographyCapaQuality ControlGmpLaboratoryTestingHplcBiopharmaceuticalsMethod Development21 Cfr Part 11BiotechnologyStandard Operating Procedure (Sop)Six SigmaChemistryGas ChromatographyManagementValidationU.s. Food and Drug Administration (Fda)GlpPharmaceutical IndustrySopFda

ABOUT CHRISTINA SCHWALBE

With broad cross-functional global cGxP expertise across Biotech/Pharma, I have extensive experience in Clinical, Biologics, Commercial Manufacturing, Small Molecules, and start-ups. I’m recognized as a strategic and motivational leader with a proven track record of delivering significant results in operations management, regulatory compliance, and manufacturing.Passionate about improving patient outcomes, I am committed to ensuring that the products we deliver help enhance patients’ quality of life. I’ve led cross-cultural sessions on Japanese-U.S. relations, focusing on regulatory expectations and strengthening collaboration with the Japanese Health Authority. As a QC leader, I oversee the entire testing process—from initiation to the issuance of Certificates of Analysis—ensuring timely, high-quality product delivery to patients. My leadership consistently drives success through impactful decision-making, fostering accountability, business growth, and strong stakeholder relationships.My Core Competencies are:Leadership | Operations Management | Communication | Quality Control | Quality Assurance | Process Improvement | Stakeholder Management | Risk ManagementWhen I am not in the office, I love traveling and food!

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