KNOWLEDGE AND SKILL REQUIREMENTS:

• Experience providing analytical support for assay development activities.
• Experience working as part of a cross functional team.
• Experience with reagent, instrument, and software development.
• Experience collaborating with external CRO/CMOs.
• Experience with change management processes.
• Solid knowledge of basic statistics.
• Experience with data analysis and graphing programs.
• Experience with automation and automated processes.
• Understanding of protein and enzyme function.

EDUCATION AND EXPERIENCE:

A BS/MS in biochemistry, chemistry, analytical chemistry, chemical engineering, or closely related field with at least two years’ experience in industry or an equivalent combination of experience and/or education required.

PHYSICAL REQUIREMENTS:

Frequently sit, frequently stand, and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, occasionally climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Frequently look at detailed information on computer screens and in printed form. Occasionally lift of carry 11 – 25 lbs. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Occasionally exposed to fumes, airborne particles, toxic or caustic chemicals. Occasionally exposed to uneven surface and vibration. Moderate noise is typical for the work environment of this job.

PURPOSE:

We are seeking a talented, collaborative and motivated Research Associate to join the Product Development team. Join us at ACC and work in a multidisciplinary environment supporting the development of new endotoxin and glucan detection products that meet ACC corporate goals using current and new technologies.

GENERAL RESPONSIBILITIES:

• The major responsibilities of this position will be to support the advancement of the company product development pipeline.
• Conduct laboratory experiments and studies according to approved protocols and Standard Operating Procedures (SOPs).
• Collaborate in creating SOPs, protocols for studies, verifications, and validations.
• Participate in the development, improvement, verification, validation, and technology transfer of current and new products or processes.
• Analyze laboratory results and prepare study reports.
• Understand and follow Design Control requirements for the development of new products and processes
• Participate in cross-functional activities.
• Maintain records in accordance with Quality Assurance guidelines.
• Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products.