Experience

Alder BioPharmaceuticals, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, Bioanalytical

  • 2012 - 2015

  Provided bioanalytical and CRO management support for nonclinical and clinical studies. Provided bioanalytical and CRO management support for nonclinical and clinical studies.



XOMA

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director, Bioanalytical Development

  • 2007 - 2012

  Established and managed a GLP bioanalytical lab to support IND-enabling nonclinical and Phase I - III clinical studies for drug products including bio-defense program. Developed, validated, and conducted/transferred bioassays as well as immunoassays in ELISA and/or MSD ECLA format for PK and immunogenicity assessment. Managed CROs for additional bioanalytical support to complement internal capability. Served as project team member for projects providing expertise in bioanalytical… Show more Established and managed a GLP bioanalytical lab to support IND-enabling nonclinical and Phase I - III clinical studies for drug products including bio-defense program. Developed, validated, and conducted/transferred bioassays as well as immunoassays in ELISA and/or MSD ECLA format for PK and immunogenicity assessment. Managed CROs for additional bioanalytical support to complement internal capability. Served as project team member for projects providing expertise in bioanalytical and GLP areas. Planned and managed operation budgets resulting in meeting budget limits consistently. Trained personnel for annual GLP certification. Successfully passed a GLP audit by FDA.

• Manager, Bioanalytical Development

  • 2004 - 2007

  Established a GLP bioanalytical lab to support non-clinical and clinical studies. Hired and managed personnel to develop, validated and conduct bioanalytical assays.

• Scientist II, Analytical Biology

  • 2001 - 2004

  Developed, qualified/validated, and conducted ligand-binding assays in support of non-clinical and clinical studies.



Chiron Corporation

• United States
• Biotechnology
• 100 - 200 Employee

• Research Specialist II/Clinical Data Coordinator III

  • 1995 - 2001

  Established a BL2 lab to facilitate technology transfer for MenC vaccine project. Optimized ELISA automation systems for vaccine projects leading to significantly reduced failure rate. Developed and validated ELISA and cell culture assays under GLP to support vaccine program. Received an Employee Excellence Award for setting up and optimizing lab automation processes to improve efficiency and accuracy. Managed electronic data transfer from central laboratories… Show more Established a BL2 lab to facilitate technology transfer for MenC vaccine project. Optimized ELISA automation systems for vaccine projects leading to significantly reduced failure rate. Developed and validated ELISA and cell culture assays under GLP to support vaccine program. Received an Employee Excellence Award for setting up and optimizing lab automation processes to improve efficiency and accuracy. Managed electronic data transfer from central laboratories ensuring data integrity in ClinTrial. Prepared and updated SOPs, validation, and technical reports in compliance with GLP for clinical and nonclinical studies. Show less Established a BL2 lab to facilitate technology transfer for MenC vaccine project. Optimized ELISA automation systems for vaccine projects leading to significantly reduced failure rate. Developed and validated ELISA and cell culture assays under GLP to support vaccine program. Received an Employee Excellence Award for setting up and optimizing lab automation processes to improve efficiency and accuracy. Managed electronic data transfer from central laboratories… Show more Established a BL2 lab to facilitate technology transfer for MenC vaccine project. Optimized ELISA automation systems for vaccine projects leading to significantly reduced failure rate. Developed and validated ELISA and cell culture assays under GLP to support vaccine program. Received an Employee Excellence Award for setting up and optimizing lab automation processes to improve efficiency and accuracy. Managed electronic data transfer from central laboratories ensuring data integrity in ClinTrial. Prepared and updated SOPs, validation, and technical reports in compliance with GLP for clinical and nonclinical studies. Show less



XOMA

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Scientist III/II/I/Lab Supervisor

  • 1989 - 1995

  Supervised a group to provide bioanalytical support to preclinical and clinical studies by developing and performing PK, PD and immunogenicity assays in ELISA format. Prepared and revised scientific publications, SOP and bioanalytical reports. Supervised a group to provide bioanalytical support to preclinical and clinical studies by developing and performing PK, PD and immunogenicity assays in ELISA format. Prepared and revised scientific publications, SOP and bioanalytical reports.