Research Associate Ii

PURPOSE:

In this role, you will work in a multidisciplinary environment where Biology and Medicine meet Engineering, Chemistry and Manufacturing to support the development of new endotoxin and glucan detection products.

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
• Follow Design Control requirements and SOPs in a GMP environment
• 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
• Knowledge of basic statistics
• Experience with automation and automated processes
• Understanding of protein and enzyme function

EDUCATION AND EXPERIENCE:

A BS/MS in biochemistry, chemistry, analytical chemistry, or closely related field with 2+ 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

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.

BENEFITS:

• 401(k)/ with a company match up to 6%
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance