Advanced Research Associate - Aseptic Processing
Bio-Techne
Position Summary:
The Advanced Research Associate supports the development and sustained manufacture of Bio-Techne’s product portfolio, executing and revising SOPs, facilitating controlled experiments, and collaborating cross-functionally to advance new and existing products while improving processes and ensuring compliance.
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.
- Propose and implement process improvement initiatives.
- Conduct workspace walkthroughs, close out actions, and perform device calibrations.
- Collaborate with cross-functional teams.
- Perform training for new employees and contribute to team development.
- Comply with safety, quality, and regulatory requirements; perform additional duties as assigned.
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/Knowledge:
- GMP and GDP knowledge required.
- Strong aseptic filling technical knowledge; exposure to media fills and aseptic process qualification.
- Ability to work in laminar flow hoods and RABS.
- Proficiency with Microsoft Word, Excel, PowerPoint.
- Ability to perform moderately complex data analysis and calculations.
- Strong organization, attention to detail, verbal/written communication, training ability, and multitasking.
Working Conditions/Physical Requirements:
- Onsite during standard business hours; occasional extended hours.
- Wear PPE and clean room attire; stand/sit for extended periods; manual dexterity; lift up to 25 lbs.
Benefits (as stated):
- Competitive insurance benefits starting on day one; 401k, ESPP, HSA, FSA, Dependent Care FSA; paid holidays/PTO/paid parental leave; mentorship/training/tuition reimbursement.
Application instructions:
- For reasonable accommodation during the application process, contact hr@bio-techne.com.