Advanced Research Associate – Viral Clearance

4d4 days ago

Bio-Techne

Minneapolis, US · Full-time · $70,000 – $95,000

About this role

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. As an Advanced Research Associate on the Viral Clearance team, you will apply chromatography, cell culture, bioassays, and molecular biology techniques to evaluate the impact of various purification conditions on the inactivation and removal of model viruses from our products.

Working in a BSL-2 laboratory environment, you will assess viral clearance using animal-derived model viruses and contribute directly to ensuring product safety for GMP products. You will also support the development of new methods and prepare summary reports that document the effectiveness of manufacturing processes to clear viral loads in support of regulatory submissions.

You will collaborate closely with Operations, Process Engineering, Quality Assurance, Quality Control, and Regulatory Affairs to ensure consistent and robust process performance. In this role, you will work with animal-derived model viruses in an environmentally controlled facility and have the opportunity to contribute to process improvements while performing additional duties as assigned.

This position offers the chance to apply your scientific drive to understanding how manufacturing processes can impact product safety, and to participate in cross-functional projects and team meetings. You will perform troubleshooting investigations and identify continuous improvement opportunities to enhance testing quality and operational efficiency.

Requirements

Bachelor's degree in Biological Sciences or a related field with a minimum of 3-5 years of relevant laboratory experience, or a Master's degree with up to 2 years of relevant laboratory experience
Industry experience, including familiarity with GMP environments, is preferred
Experience with viral clearance methodologies is preferred
Knowledge of cell culture, protein chemistry, molecular biology, and associated laboratory techniques, with demonstrated hands-on proficiency
Understanding of quality systems and experience working in regulated environments (e.g., GMP, ISO)
Attention to detail, organizational skills, and demonstrated proficiency in data analysis and problem-solving
Critical-thinking skills, with the ability to apply technical knowledge to troubleshooting and project execution
Ability to produce accurate, high-quality work and maintain thorough documentation

Responsibilities

Develop and conduct moderately complex experiments and report test results in compliance with SOPs and GxP standards
Maintain accurate, complete, and audit-ready laboratory and product documentation, including drafting and revising SOPs
Support projects and new product development
Prepare technical reports and clearly communicate findings to team members and key stakeholders
Participate in new method development and validations, as well as cross-functional projects and team meetings
Perform troubleshooting investigations
Identify and implement continuous improvement opportunities to enhance testing quality and operational efficiency
Collaborate with Operations, Process Engineering, Quality Assurance, Quality Control, and Regulatory Affairs to ensure consistent and robust process performance

Benefits

Opportunity to contribute to process improvements in an environmentally controlled BSL-2 facility
Work with animal-derived model viruses to support regulatory submissions for GMP products
Collaborate cross-functionally with Operations, Process Engineering, QA, QC, and Regulatory Affairs
Participate in new method development and validation projects