Advanced Research Associate - Manufacturing

Asuragen, Inc.; Austin (TX); On-site; USD 50,000 - 82,000; Full time

Job summary

Bio-Techne in Texas is seeking an Advanced Research Associate to support end-to-end production with focus on formulation and quality control of reagents, ensuring compliance with cGMP/GLP/ ISO standards. Responsibilities include following manufacturing protocols, testing products, documenting non-conformances, maintaining inventory, and assisting in equipment maintenance and validation.

Qualifications include a Bachelor's degree in a scientific discipline and 2–5+ years in production; experience

Qualifications

• Bachelor’s degree in a scientific discipline and 2–5+ years in production.
• Experience in molecular assays, PCR/CE, qPCR or NGS preferred.
• Familiarity with cGMP, GLP, ISO or other regulated environments.
• Proficient in MS Office and database management.
• Strong data recording and documentation skills.
• Ability to work in a fast-paced manufacturing setting.

Responsibilities

• Follow manufacturing protocols to formulate reagents.
• Functionally test products, reviewing data obtained for compliance to established specifications.
• Assist in downstream production by following work instructions to fill, label and package reagents.
• Maintains quality of manufactured products; recording information accurately while following Good Documentation Practices as well as verifying work performed by co-workers.
• Document non-conformances and deviations.
• Follows work instructions to inspect, test and release raw materials.
• Perform rework as required according to designated work instructions.
• Coordinate and perform equipment maintenance.
• Perform equipment validation as required.
• Perform product stability testing according to work instructions.
• Maintain accurate inventory through the timely and accurate completion of work order and inventory transactions and by performing weekly cycle counts.
• Perform general lab maintenance, cleaning, and organization.
• Execute work in a safe manner.
• Notifying management of any safety issues or risks and assisting in remediation of those safety issues or risks.
• Apply experience and logic to resolve a variety of moderately complex problems.
• Provide support for cross-functional teams on complex projects.
• Identify and implement process improvements.
• Revise and update procedures as needed.
• Perform all other duties as assigned.

Skills

Molecular assays

PCR/CE

qPCR

NGS

Lean manufacturing

cGMP/GLP/ISO

ERP systems

Teamwork

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Database management

Job description

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. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. Pay Range: $49,700.00 - $81,650.00 Position Summary The Advanced Research Associate will have experience running and troubleshooting molecular assays, preferably in a manufacturing environment. This role will support end to end production with primary focus on the formulation and quality control of reagents prior to being processed into finished kits.

Key Responsibilities

• Follow manufacturing protocols to formulate reagents.
• Functionally test products, reviewing data obtained for compliance to established specifications.
• Propose solutions to technical issues with management or technical lead prior to executing.
• Assist in downstream production by following work instructions to fill, label and package reagents.
• Maintains quality of manufactured products; recording information accurately while following Good Documentation Practices as well as verifying work performed by co-workers.
• Document non-conformances and deviations.
• Follows work instructions to inspect, test and release raw materials.
• Perform rework as required according to designated work instructions.
• Coordinate and perform equipment maintenance.
• Perform equipment validation as required.
• Perform product stability testing according to work instructions.
• Maintain accurate inventory through the timely and accurate completion of work order and inventory transactions and by performing weekly cycle counts.
• Perform general lab maintenance, cleaning, and organization.
• Execute work in a safe manner.
• Notifying management of any safety issues or risks and assisting in remediation of those safety issues or risks.
• Apply experience and logic to resolve a variety of moderately complex problems.
• Provide support for cross-functional teams on complex projects.
• Identify and implement process improvements.
• Revise and update procedures as needed.
• Perform all other duties as assigned.

Knowledge, Skills, And Abilities

• Experienced in the setup and analysis of Molecular assays, PCR/CE, qPCR and NGS preferred.
• Skilled in the use of software programs such as Microsoft Office and database management programs.
• Organized, process-oriented individual with an attention to detail.
• Good time management skills.
• Ability to perform repetitive tasks with high degree of accuracy.
• Good written and communication skills.
• Able to work in a fast-paced environment.
• Readily adaptable to changing demands.
• Familiarity with ERP systems, QAD a plus.
• Ability to work cohesively in a team environment.
• Knowledge of lean manufacturing principals.
• Knowledge of cGMP, GLP, ISO, CE or other regulated environments.

Education and Experience

Bachelor’s degree in a scientific discipline or equivalent and 2-5+ years’ experience in a production environment; or a combination of education and applicable work experience.

Why Join Bio-Techne:

We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield. We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA. We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more. We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging. We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an E-Verify Employer in the United States. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property. This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance. Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.