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Bioanalytical Scientist

Drug Metabolism/Pharmacokinetics

SUMMARY:

Working in a GLP environment, the Bioanalytical Scientist is responsible for day-to-day execution of bioanalytical protocols in support of Phase 1 clinical trials, including pharmacokinetics, absolute bioavailability, metabolite profiling, mass balance and microdosing studies. Clinical studies are conducted using compounds that are lightly labeled with 14C isotope. These Phase 1 studies are typically performed in 6-18 healthy volunteers over several days at a single clinical site. The clinic submits the samples to Accium BioSciences for processing and quantitation on Accium’s 0.5 mV Accelerator Mass Spectrometer (AMS), an ultra-sensitive mass spectrometer capable of quantifying drugs present at attomole (10^-18 M) concentration. The Bioanalytical Scientist is responsible for front-end sample preparation, HPLC and processing prior to transfer to Graphitization and AMS Laboratories. The position reports to the Study Director.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Receive and log samples submitted for analysis from outside clinics
Aliquot clinical samples in batch form for drying and transfer to Graphitization Laboratory
Transfer extraction and HPLC methods from Sponsor and demonstrate satisfactory reproduction of method at Accium
Extract clinical samples such as plasma
Perform HPLC and collect fractions by fraction collector
Perform Total Carbon assay using Total Carbon Analyzer
Perform additional preparation and processing of clinical samples as described in Bioanalytical Protocols
Assemble data produced by the AMS instrument in client-specific spreadsheet
Closely co-ordinate activities with Study Director, Graphitization Laboratory, AMS Laboratory, Purchasing, Quality Assurance and Sponsor.
Participate in the evaluation, training and refining of departmental SOPs and guidelines, and the development of standard reports, templates and forms.
Problem-solve logistical issues related to Project Management

Requirements:

Bachelors Degree in scientific discipline
4+ years laboratory experience
GLP or GMP experience
Strong oral and written communicator
Time-management skills
Must work methodically on time-critical study elements

About Accium BioSciences:

Accium BioSciences is a privately-held contract research company offering ultrasensitive bioanalytical services in support of early-phase clinical trials. The company’s clients are primarily large pharmaceutical companies investigating the bioavailability, pharmacokinetics and metabolism (PK/ADME) of new chemical entities. Our services are based on accelerator mass spectrometry (AMS), a detection platform for quantifying drugs and metabolites in clinical samples with unprecedented sensitivity. In April 2006, Accium BioSciences launched the first US-based AMS Facility in the U.S dedicated to pharmaceutical services. The company is based in Seattle, Washington.

For more information, please visit www.acciumbio.com, or call Ali Arjomand (206) 281-3915, e-mail arjomand@acciumbio.com.