Applied Precision, Inc.

Senior Research Associate, Product Development/Formulations

Since its founding in 1986, Applied Precision has grown into a leader in the development, manufacture and supply of high-performance image acquisition and analysis systems for the life science industries. The company's products play a key role in providing the quantifiable data and meaningful information needed to advance technology and realize important scientific discoveries. The company’s culture encourages teamwork, recognizes the importance of balancing work with personal time and rewards innovative thinking.

Department: RareCyte

General Position Summary:

We are on a mission is to detect, characterize and diagnose cancer at the earliest possible stage through a simple blood test. Our proprietary technology has the potential to become the standard of care for cancer detection and treatment monitoring. Our employees have the opportunity to make a difference in people’s lives by advancing cancer diagnostics. We are seeking talented individuals to join our team developing these novel diagnostic tests. The Research Associate will support this effort by developing, delivering and ensuring the quality of reagents for diagnostic applications.

Responsibilities:

• Provide technical leadership to support product and process development.
• Identify and develop technology for bioconjugation and scale-up for diagnostic tests.
• Prepare specifications to ensure process consistency, quality and stability.
• Perform scale-up for transition to manufacturing and define QC tests for production.
• Translate customer/product requirements into design specifications.
• Interface with Contract Manufacturing Organization (CMO) to transfer methods for the development of diagnostic kits.
• Establish documentation in compliance with FDA regulations for manufacture of reagents for a Class II Diagnostic Device.
• Write Standard Operating Procedures (SOP’s) to support maintaining sample inventory, storing samples, preparing reagents and solutions, and maintaining laboratory equipment.
• Document results in laboratory notebook, written reports or presentations.
• Analyze, interpret and present results to the project team.
• Work closely with multi-disciplinary team in collaborative environment.

Qualifications:

• B.S. or M.S. in biochemistry, chemistry or a related field.
• A minimum of 5 years experience developing, validating and verifying materials and processes for in-vitro clinical diagnostics.
• Must have experience with commercializing an in-vitro diagnostic product in an FDA regulated environment.
• cGMP and GLP proficiency.
• Strong communication skills and ability to communicate to a multi-disciplinary team.

Applied Precision believes that each employee makes a significant contribution to the company’s success. That contribution should not be limited by the assigned responsibilities. Therefore, this position description is designed to outline primary duties, qualifications and job scope, but not limit the incumbent nor the organization to just the work identified. It is our expectation that each employee will offer his/her services wherever and whenever necessary to ensure the success of our endeavors.

Applied Precision, Inc.

Applied Precision, Inc. is an Equal Opportunity Employer

Submitted: 07/07/2010