Lien Pham Email & Phone Number

California, United States

San Diego, CA, US

I author network standards/procedures to define quality governance to be implemented at individual sites, which includes gap and risk assessments with site representatives, to meet corporate goals.I work collaboratively with individual sites to incorporate the network's vision for the biologics and vaccine franchises, ensuring that best practices are.

South San Francisco, California, US

I represented the interests of the patients, advocating for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for all products sent to patients through third parties, enabling distribution of medically needed products globally.I oversaw all quality aspect of divestment deals, including due diligence and negotiation of contractual.

South San Francisco, California, US

I was the single point of contact for international relationships with third parties for commercial manufacturing and distribution of products globally.I organized, coordinated and hosted third party technical visits per contractual obligations, enabling alignment between manufacturing and testing procedures with third party's dossier.I authored, prepared.

US

Responsible for project management of all work performed at US and UK contract labs to ensure deliverables are within project scope, timeline, and budget.Review and approve all protocols and reports generated by contract labs for potential inclusion in US filing.Collaborate with Japanese partners to ensure FDA requirements for an IND application are met.

Supervised and managed six chemists in the testing of drug coated stents.Coordinated and review QC data for compliance/accuracy and investigated atypical data.Approved engineering protocols, analytical development reports, validations, and stability reports for accuracy, clarity, and compliance to company policies and ICH guidelines.Investigated the.

South San Francisco, California, US

Responsible for the routine testing of commercial products, including all Certificate of Analysis testing. Duties included investigation and resolution of assay issues and atypical results. Collaborated with Critical Reagents team to qualify new lots of controls and references.