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.
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.
GENERAL COMPETENCIES:
· Excellent written and verbal communication skills required.
· Strong record keeping and organizational skills with excellent attention to detail.
· Ability to work independently with minimal supervision.
· Ability to manage multiple projects and priorities
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