Experience

Analytical Biological Services
• United States
• Biotechnology
• 1 - 100 Employee
• Biorepository Manager

  • Dec 2010 - Present


US

• Design Services
• 1 - 100 Employee

• CPU Laboratory and Outsourcing Manager

  • May 2006 - Present

  Responsible to equip, staff and manage the pK and sample-processing laboratory. Review safety and pD data. Responsible for managing all outsourced vendors. Manage safety laboratory vendor, specialty laboratory vendors and multiple service vendors in support of the daily operations of the CPU. Ensure Biosafety and OSHA training and compliance for laboratory and clinical personnel, chair CPU Biosafety Committee. Collaborate with study physicians, coordinators, nurses, clinical technicians… Show more Responsible to equip, staff and manage the pK and sample-processing laboratory. Review safety and pD data. Responsible for managing all outsourced vendors. Manage safety laboratory vendor, specialty laboratory vendors and multiple service vendors in support of the daily operations of the CPU. Ensure Biosafety and OSHA training and compliance for laboratory and clinical personnel, chair CPU Biosafety Committee. Collaborate with study physicians, coordinators, nurses, clinical technicians, and phlebotomists to allocate resources required by clinical trials. Manage costs and cost-efficiency of laboratory personnel, including Laboratory Operations Specialists and CPU Clinical Technicians. Manage cost and cost efficiency of external contract agreements for vendors supporting the Unit operations. Provide strategic input to CPU leadership team for set-up and validation of new lab assays critical for drug development and unit functionality. Represent the AZ's US CPU during start up and opening of the Unit to negotiate, establish, and supervise service level agreements for food, housekeeping, contract lab personnel providers, safety, and specialty lab providers. Provide liaison with Corporate Real Estate personnel for lease management, maintenance, security and parking agreements. Show less


AstraZeneca
• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Business Manager and Laboratory Manager

  • Apr 2006 - Present

Professional Clinical Laboratories, Inc
• lab technician

  • Mar 1980 - Present


Glaxo SmithKline

• United Kingdom
• Wholesale
• 1 - 100 Employee

• Head

  • Jan 1980 - Present

  Prioritize workload of laboratory science Outsourcing Managers and Logistical Sample Managers. Support laboratory requirements of all studies conducted at the Glaxo SmithKline Phase I Unit. Assure completion of all critical path in-house studies, as well as support of selected external studies. Ensure support of all laboratory aspects of required Phase I safety and/or pharmacodynamic laboratory assessments. Accountable for efficient operation of the Group, ensuring that standards of all… Show more Prioritize workload of laboratory science Outsourcing Managers and Logistical Sample Managers. Support laboratory requirements of all studies conducted at the Glaxo SmithKline Phase I Unit. Assure completion of all critical path in-house studies, as well as support of selected external studies. Ensure support of all laboratory aspects of required Phase I safety and/or pharmacodynamic laboratory assessments. Accountable for efficient operation of the Group, ensuring that standards of all study responsibilities meet biosafety compliance and regulatory and corporate standards, as well as protocol and SOP requirements. Strategic Planning Operational Budgets Regulatory Compliance Biosafety Compliance GLP/GCP Compliance Data Review Workflow Analysis Performance Evaluations Selected Accomplishments: Organized group of managers to outsource and resource-manage laboratory placement for all work previously conducted internally to external providers Ensured Unit operations continued with full enrollment of all planned studies Established processes with external provider laboratories to ensure safety and pharmacodynamic analysis were guaranteed within established guidelines and expected turn-around time. Oversaw interface established between selected external provider and GSK to allow transfer of data for review to assure safety evaluation of all volunteers in Phase I studies Worked with external providers to set up assays previously conducted internally Finalized agreements for Interface, Pricing, and Service Level with external providers and GSK Directed transfer of business relationship from one external provider (Quest Diagnostics) to another external provider (Laboratory Corporation of America). Process included all aspects of method transfer, assay development, automated interface, and logistics

• Head, SEAL Labs

  • Jan 1995 - Jan 2004

  Responsibilities: Technical management of SEAL (Safety Evaluation and Assessment Laboratories), including personnel staff (research scientists, medical technologists and phlebotomists), workload scheduling, evaluation of resource and personnel requirements. Reviewed and provided input to all Phase I study protocols. Strategic Planning Operational Budgets Regulatory Compliance GLP/GCP Compliance Biosafety Training and Compliance Workflow Analysis Staffing… Show more Responsibilities: Technical management of SEAL (Safety Evaluation and Assessment Laboratories), including personnel staff (research scientists, medical technologists and phlebotomists), workload scheduling, evaluation of resource and personnel requirements. Reviewed and provided input to all Phase I study protocols. Strategic Planning Operational Budgets Regulatory Compliance GLP/GCP Compliance Biosafety Training and Compliance Workflow Analysis Staffing Optimization Training Programs SOP Writing Performance Evaluations

• Laboratory Manager/Senior Investigator

  • Jan 1995 - Jan 2001

• Senior Research Technician and Laboratory Supervisor

  • Jan 1990 - Jan 1995

  Responsibilities: Supervised four research technicians Oversaw the work in progress Assigned and monitored drug study protocols Assured laboratory staff worked in an environment to assure Good Laboratory Practices Responsible for assuring laboratory staff followed all Biosafety specifications and required documentation Monitored quality control Developed and validated new methodologies Evaluated and implemented new instrumentation and ensured compliance Performed and… Show more Responsibilities: Supervised four research technicians Oversaw the work in progress Assigned and monitored drug study protocols Assured laboratory staff worked in an environment to assure Good Laboratory Practices Responsible for assuring laboratory staff followed all Biosafety specifications and required documentation Monitored quality control Developed and validated new methodologies Evaluated and implemented new instrumentation and ensured compliance Performed and monitored general and special chemistry assays, routine screening tests, including hematology, chemistry and urinalysis Repaired, maintained and calibrated clinical laboratory equipment Inserted heparin locks and intravenous catheters Trained and oversaw the technique of others Developed inulinase method for inulin determinations as a user defined assay on the CX4 and presented abstract as co-author in poster session at 1990 AACC Convention Developed method for the application of PAH to Cobas Mira and presented abstract as author in poster session at 1991 AACC Convention

• Global Management

  • Sep 1993 - Sep 1993

• Good Laboratory Practice Training Course

  • Sep 1992 - Sep 1992

SmithKline Beecham
• United Kingdom
• Financial Services
• Frontline Leadership

  • Sep 1990 - Sep 1990
• Research Technician

  • Jan 1980 - Jan 1990

  Responsibilities: Performed all manual and automated routine and special chemistry, renal testing, hematology, and urinalysis Responsible for the conduct of the laboratory aspect of study protocols All phlebotomy procedures



ICI

• Chile
• Professional Training and Coaching

• Research Technician

  • Sep 1972 - Sep 1980

• Medical Technician

  • Jan 1972 - Jan 1973

  Responsibilities: Performed manual and automated chemistry, hematology, bacteriology, and urinalysis. shift work in a "STAT" lab for an emergency center. EKGs.



I.C

• Morocco
• Business Consulting and Services

• Laboratory Technician and Research Technician

  • Jan 1973 - Jan 1980

  Responsibilities: Performed all manual and automated routine and special chemistry, hematology, parasitology, urinalysis, and urine microscopy on research animal specimens. data evaluation. report preparation. methodology development. routine maintenance, quality control, and trouble-shooting of instruments. Achievements: Developed a cholesterol oxidase method for dogs and rats, which was presented at the Society of Toxicology Meeting