David Hooi Email & Phone Number

California, United States

Redmond, Washington, United States

San Jose, California, United States

• Provided oversight of the Quality Team > 25 team members to include QA Document Control, QA Operations, QA Client Management, QA Validation, GMP Training, and QA Compliance. Evaluate and implement quality systems from.
• Drove continuous process improvement using quality metrics for deviation closure (40% reduction average closure) and lot release generating revenues of $25 million.
• Facilitated client audits, communications, and deliverables to maintain high client satisfaction and compliance with cGMPs.
• Provided responses to the FDA for quality questions associated with the manufacture of gene therapy investigational drug product Zamtocabtagene clinical trial NCT04792489 with no additional follow-up required.

San Francisco Bay Area

• QA representative on CMC teams focused on mAb production, testing, and labeling activities. Led QA operational oversight of mAb CMO/CTL and suppliers.
• Reviewed and approved mAb Master Batch Record (MBR) in compliance with GMP regulations, regulatory filings, and quality agreements.
• Evaluated and approved executed batch records, raw analytical data, stability protocols, reports, data, and other GMP documents to enable drug substance and final drug product release for critical Covid19 antibody.
• Examined and approved change controls, deviations, and investigations at CMOs/CTLs.

South San Francisco, California

• Provided leadership and management in Quality Operations to support Clinical Manufacturing both in-house and at CMOs for Autologous Cell Therapy Products. Participated in IND amendment by reviewing several CMC sections.
• Authored, reviewed, and approved QA SOPs to support PACT Pharma Quality System (Quality Agreement, Training, Deviation, CAPA Management Program, and Document Review for Clinical Manufacturing).

South San Francisco, California

• Prepared and approved quality agreements with CMOs. Participated in IND submission by preparing and reviewing several CMC sections for Cell Therapy Products resulting in IND approval for Phase 1 Clinical Study.
• Performed audits of Contract Manufacturing Organizations (CMOs) to support supplier quality programs.

Songdo, South Korea

Provide leadership and management in Quality Operations to support Manufacturing activities in Drug Substance Plant 1 to ensure timely delivery with high quality product. Communicate and interact with multiple stakeholders for example Business Units (Plant 1, Plant 2 and Aseptic Filling), Functional teams (Manufacturing, Materials Management, Quality.

Santa Clara, California

Responsible for the implementation, maintenance and adherence to quality systems to ensure high quality deliverables for clinical and commercial use.Lead and managed Non-Conformance Investigations, Change Control and Corrective and Preventative Actions.Participated in a successful Pre-Approval Inspection with regulatory agency (FDA) for Pandemic Flu.

Mountain View, California

Participated in the design and implementation of quality systems for Cell Therapy project.Quality Assurance Technical Transfer (QATT) representative from clinical to commercial for several late stage development projects utilizing drug delivery system – OROS oral delivery.Quality on the Floor for line clearance activities and manufacturing partnership.

Malvern, Pennsylvania

Initiated, investigated and resolved non-conformances in cell culture manufacturing within 30 days.Revised standard operating procedures and master batch records in Cell Culture Manufacturing to address CAPAs.Implemented process excellence concepts of lean thinking to improve batch record management. Provided GMP consultations and training to business.

Malvern, Pennsylvania

Participated in a successful PAI for a $200 million facility.Participated in the implementation of an enterprise resource planning system (SAP) in a cGMP manufacturing environment.Established systems for documentation management of batch records, standard operating procedures (SOP) and QC test results.Achieved > 95% accuracy for inventory.

San Diego, California

Attained > 90% success for cell culture operations attempted.Supervised and generated goals and expectations for a team of 4 technicians.Investigated and completed Manufacturing variance reports.Reviewed batch records daily for correct GMP documentation to minimize delays in Quality Assurance lot release.Investigated process anomalies related to dO2.

South San Francisco, California

Managed operations in CCP to support marketed products and cell culture process development runs.Supervised and generated goals and expectations for a team of 10-14 technicians.Participated in a successful FDA inspection for multi-product facility.

South San Francisco, California

Performed a variety of manufacturing operations; including media preparation, cell culture, bacterial fermentation and purification.

Bachelor Of Science - Bs, Liberal Arts And Sciences, Concentration In Chemistry

Master Of Business Administration - Mba, New Venture Small Business Management

High School, General