Position Summary:
The Advanced Research Associate supports the development and sustained manufacture of Bio-Techne’s product portfolio. Executes and revises standard operating procedures, facilitates controlled experiments, and collaborates cross-functionally to advance new and existing products. Implements process improvements, ensures compliance with quality standards, and supports operational excellence.
Key Responsibilities:
- Author, revise, and execute Standard Operating Procedures (SOPs) for manufacturing reagents and consumables.
- Facilitate moderately complex controlled experiments for new product development.
- Perform validation activities for equipment used in GMP manufacturing.
- Follow Good Documentation Practices (GDP) to capture results, analyze data, and prepare reports.
- Perform timely reviews of in-process manufacturing documentation.
- Identify and resolve manufacturing process issues.
- Investigate and author non-conformance reports; lead troubleshooting activities.
- Propose and implement process improvement initiatives.
- Conduct workspace walkthroughs, close out actions, and perform device calibrations.
- Collaborate cross-functionally to achieve project objectives.
- Perform training for new employees and contribute to team development.
- Comply with safety, quality, and regulatory requirements.
Qualifications:
- Bachelor’s degree with 3–5 years relevant experience, or Master’s degree with up to 2 years relevant experience.
- GMP laboratory experience required.
Skills/Abilities (Required/Preferred):
- Knowledge of GMP and GDP required.
- Preferred: technical knowledge of fermentation (E. coli bioreactor), protein purification (TFF, chromatography, filtration, dialysis), and/or aseptic filling.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Ability to perform moderately complex data analysis; strong organization and attention to detail.
- Effective verbal and written communication; ability to conduct training; multitask and prioritize.
Working Conditions:
- Onsite work during standard business hours; occasional extended hours as needed.
Physical Requirements:
- Stand/sit for extended periods; manual dexterity; lift up to 25 lbs as needed.