Biotechne · San Marcos, CAPrepare for this interview
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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: $52,000.00 - $85,600.00 Position Summary: Responsible for developing controls, calibrators, working solutions, and intermediates according to approved standard operating procedures. Responsible for developing quality products on schedule. General knowledge and basic application of concepts, theories, terminology and practices that apply to research in a laboratory environment. Duties and Responsibilities: Research Associate Develop and manufacture OEM diagnostic controls and calibrators for clinical chemistry and immunoassay applications including Cardiac Markers, Immunochemistry, Lipids, Urinalysis, Coagulation, Tumor Markers, and other protein or small molecule analytes. Support new product development by assisting with formulation development, optimization, and refinement of existing products. Execute manufacturing and development procedures in accordance with approved SOPs, while maintaining complete, accurate , and contemporaneous GMP documentation. Design and execute controlled experiments to support troubleshooting, root cause analysis, process optimization, and formulation development. Prepare technical summaries and reports to support design control activities, including feasibility, development, validation, and transfer documentation. Design, validate , and transfer product formulations in compliance with design control and change management requirements. Perform in process testing, calculations, and adjustments to ensure analytes meet defined specifications. Analyze raw materials, intermediates, and final products using both automated and manual analytical instrumentation. Verify that analytical instrumentation, clinical chemistry analyzers, and point of care devices are operating correctly; perform or confirm calibration and maintenance prior to use as required . Accurately measure and prepare solutions using volumetric and gravimetric techniques, applying knowledge of chemical and biochemical properties and safe handling practices. Author, review, and revise SOPs, work instructions, QCRs, and related quality documentation; implement changes through formal change control processes. Perform manufacturing and processing steps such as centrifugation, filtration, diafiltration, column separation, and buffer exchanges as required . Design, execute, and analyze stability studies for new and existing products, including data trending and reporting. Perform aseptic techniques including sterile filtration, filling, capping, and microbial plating in accordance with GMP requirements. Support equipment and process validation activities including IQ/OQ/PQ testing. Assist with technical transfer of products and processes to manufacturing or operations teams, including training support as needed. Contribute to continuous improvement initiatives aimed at increasing efficiency, robustness, and cost effectiveness. Maintain laboratory cleanliness, organization, and equipment readiness in compliance with safety and quality standards. Participate in special projects and perform additional duties as assigned. Minimum Job Requirements: Bachelor's degree in Chemistry, Biochemistry, Biological Science, or related field preferred with 1-5 years work experience in In Vitro diagnostics, medical device, pharmaceutical or related industry required. 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.
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