Confidential Gene Therapy Company

Responsible for driving GMP production at CDMO of Phase 1 Clinical material: batch record review, event/deviation investigations and closure, batch disposition, resolving road blocks with CDMO.

Quality Consultant

Vong BioPharma

Providing project management, process engineering and compliance consulting services to the Medical Device, Biotech and Pharmaceutical industries.

FDA Regulated Industry Consultant

Confidential CDMO

Assisting with improving the gene therapy program improvements: standardizing tech transfer, materials and documentation for AAV gene therapy processes.

Program Manager

Confidential client

Preparing Quality by Design (QbD) deliverables for sa-mRNA vaccine including delivering training to CMC delivery team on QbD deliverables and running workshops to complete Quality Target Product Profile and Critical Quality Attributes.

Project Manager

Confidential Gene Therapy Client

Managing CDMO relationship for gene therapy client. Responsible for driving GMP production at CDMO of Phase 1/2 Clinical material: batch record review, event/deviation investigations and closure, sampling plans, process specifications, etc. Conducted annual quality audit of CDMO.

Program Manager Tech Ops & Quality

Confidential COVID-19 Vaccine Manufacturer

Conduct audit of CDMO for COVID-19 vaccine manufacturer.

Audit of CDMO

Ginkgo Bioworks, Inc.

Assist high through put COVID-19 testing  with procuring materials for PCR testing. Procure all commodities and reagents needed to start up of new laboratory in California.

Project Manager for Procurement and Supply Chain

Sterile injectable manufacturer

Project managing six sterile injectable products through the Quality by Design process. Preparing documentation for Critical Quality Attributes, Critical Process Parameters against Unit Operations and process FMEAs.

QbD Project Management

Confidential Specialty Pharmaceutical Manufacturer

Provided project management and compliance expertise for  CAPA investigations and qualifications.

Consultant

Confidential In Vitro Diagnostic Manufacturer

•	Improved first pass acceptance rate of ELISA product by reviewing DHF, quality testing procedures and manufacturing processes. 
•	Determined potential root causes for low first pass acceptance rate.
•	Designed experiments to characterize assay performance and support re-submission to FDA.

Experienced technical professional with over 15 years of experience in the pharmaceutical and medical device industries. Management experience encompasses engineering, validation and qualification areas. Project management expertise includes process validation, compliance initiatives, capital projects, validation quality, and qualification. Demonstrated ability to lead teams, problem solve and drive for results in highly matrixed environments.

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