Senior Consultant, Biologics Consulting Group, Inc.
Thousand Oaks, CA.

Director (2006), Associate Director (2005), Amgen, Inc., Thousand Oaks, CA.

Operational Achievements:

• Point person for quality and scientific guidance regarding resolution of product quality issues, i.e. nonconformances, investigations, complaints, etc.
  
• Responsible for creating and continuously improving corporate quality systems for commercialization operations across sites
  
• Identified and implemented several Corporate Product Quality initiatives and business processes to improve quality standards during development and manufacturing operations
  
• Championed templating specification setting processes and strategies for products in development
  
• Senior Management Reviewer for CMC submissions to global regulatory agencies- advisor for regulatory requirements, submission strategies, document content, and policy clarification
  
• Liaison to Quality Analytical Laboratories and Analytical Sciences regarding method development and optimization to improve utility, compliance and robustness

Managerial Responsibilities:

• Head of Global Product Quality Leaders-those (seven) individuals that are the scientific champions and technical experts of Amgen's marketed products and drug delivery systems
  
• Dotted line manager to the entire Product Quality Leader organization (approximately 45 people) requiring oversight of quality standards and practices for all development products and their associated processes, i.e. manufacturing, fill/finish, specifications, lot release, etc.
  
  

Division of Oncology Drug Products, Office of New Drug Chemistry, CDER, FDA.

Reviewer. Division of Therapeutic Proteins, Office of Therapeutics Research and Review, CBER, FDA.

• Primary product reviewer/regulator for several licensed products including growth factors (erythropoetins, bone morphogenic proteins), thrombolytics, kinase inhibitors, anti-angiogenic drugs, and bioterrorism therapeutics
  
• Primary product reviewer of the Chemistry, Manufacturing and Controls portions of Investigational New Drug applications for a variety of proteins and small molecules
  
• Inspector of cGMP manufacturing facilities
  
• Received CDER award (2004) for Regulatory Excellence
  
• Received Division of Oncology Drug Products Award (2005) for Exemplary Service
  
• Consult reviewer for Center for Devices and Radiologic Health regarding biologic/device and drug/device combination products
  
• Developed training documents for new reviewers
  

Scientist, Human Genome Sciences, Inc., Rockville, MD.

Scientific Achievements:

• Established cell lines from several human, bovine and murine primary cells using retrovirus producing cell lines generated, including human and murine bone marrow stromal cell lines capable of supporting pluripotent stem cell expansion and maintenance long-term
  
• Developed and oversaw multiple bioassays, including whole cell and biochemical formats, required for identification and development of clinical therapeutic candidates
  
• Developed whole cell screens to detect uncharacterized protein activities on a variety of target cells
  

Managerial Responsibilities:

• Project leader for team charged with developing pre-clinical candidates to the IND stage
  
• Trained and supervised others regarding GLP assay requirements, performance and procedures
  
• Authored SOPs, portions of INDs
  
• Supervised two research associates
  
• Departmental project coordinator for protein screening projects
  

Research Investigator (1996), Associate Research Investigator (1995), Bracco Research USA Inc., Princeton, NJ.

• Designed and performed in vitro screens to identify and evaluate potential in vivo diagnostic imaging compounds directed against infection/inflammation, oncology, and atherosclerosis
  
• Employed phage display against biochemical and whole cell targets to identify peptides with selective affinities
  
• Received Bracco Distinguished Service Award (1996) for team leadership, championing a biotechnology solution, and identifying lead compounds
  
• Assisted in the development and implementation of in vivo models for preclinical evaluation of potential contrast agents
  

Postdoctoral Research Fellow, Princeton University, Princeton, NJ.

Laboratory of Dr. Ihor R. Lemischka

• Identified totipotent hematopoietic stem cell specific genes
  
• Advanced the purification of hematopoietic stem cells from murine fetal liver and adult bone marrow
  
• Characterized the differentiation capacities of stem cells

Graduate Research Assistant, Columbia University, New York, NY.

Laboratory of Dr. Richard K. Assoian

• Doctoral Thesis: "A Phorbol Ester-Regulated Ribonuclease System Controlling Transforming Growth Factor-ß1 Gene Expression in Hematopoietic Cells"
  
• Assessed RNA distribution and stability in human cell lines during in vitro differentiation
  
• Identified stability regulatory regions of the TGF-ß1 transcript
  
• Examined the potential for TGF-ß1 translational control
  

Research Associate, University of California at San Francisco, CA.

Laboratory of Dr. John A. Clements

• Investigated the functions, biochemical characteristics and metabolism of pulmonary surfactant.
  
• Utilized in vivo models and isolated primary cells
  

Research Assistant, Stanford University, Stanford, CA.

Laboratory of Dr. Henry S. Kaplan

• Increased and stabilized the lymphocytic production of monoclonal antibodies
  

Vascular Endothelial Growth Factor 2. Rosen, C.A., Albert, V.A., Ruben, S.M., and Wager, R.E. Patent #20050059117. Issued on March 17, 2005.