Advanced Research Associate- Aseptic Processing
Bio-Techne
Position Summary
The Advanced Research Associate supports the development and sustained manufacture of a diverse product portfolio. Executes and revises standard operating procedures, facilitates controlled experiments, and collaborates cross-functionally. Implements process improvements, ensures quality compliance, and supports operational excellence in a fast-paced environment.
Key Responsibilities
- Author, revise, and execute Standard Operating Procedures (SOPs) for manufacturing reagents and consumables.
- Facilitate moderately complex controlled experiments to support new product development.
- Perform validation activities for equipment used in GMP manufacturing processes.
- 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 cross-functionally to achieve project objectives.
- Train new employees and contribute to team development.
- Follow safety, quality, and regulatory requirements; perform additional duties as assigned.
Qualifications
- Bachelorβs degree with 3β5 years relevant experience, or Masterβs degree with up to 2 years relevant experience.
- GMP laboratory experience required.
Knowledge/Skills
- Knowledge of GMP and GDP; strong aseptic filling knowledge.
- Exposure to media fills and aseptic process qualification.
- Ability to work in laminar flow hoods and RABS.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Moderately complex data analysis and calculations; strong organization and communication.
- Ability to multitask and prioritize; effective training ability.
Working Conditions/Physical Requirements
- Onsite during standard business hours; occasional extended hours.
- Stand/sit for extended periods; wear PPE and clean room attire; manual dexterity; lift up to 25 lbs.
Benefits (as listed)
- Insurance benefits starting on day one (medical, dental, vision, life, short- and long-term disability, pet, legal and ID shield).
- 401k, ESPP, HSA, FSA, Dependent Care FSA.
- Paid holidays/PTO and paid parental leave; tuition reimbursement and training.
Application Instructions
- For reasonable accommodations during the application/interview process, contact hr@bio-techne.com.