Research Associate - Advanced
Job Details
San Marcos, CA - San Marcos, CA
Full Time
Bachelor's Degree
Product Development

By joining Bio-Techne, San Marcos you’ll join a proven leader in the Manufacturing of In-Vitro Diagnostics.  Our Research Associates are focused on the product development of diagnostic assays, to include reagents, calibrators, controls, calibration verifiers and proficiency testing.  When you join us, you will be part of a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all its brands, provides tools for researchers to further treat and prevent disease worldwide.

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. 

Key Responsibilities:

  • Create new products using approved procedures and keep detailed and accurate records.
  • Prepare summary reports for Feasibility, Development, and Transfer as required.
  • Perform in-process analyses and determine adjustments to bring analytes into specification
  • Analyze products, stock solutions, and raw materials using automated and manual instrumentation
  • Evaluate that the analysis instrumentation and procedure is operating correctly, and verify or perform maintenance before use
  • Measure accurately quantities of material volumetrically and gravimetrically, employing knowledge of chemical and biochemical properties and handling procedures
  • Continually evaluate and/or create work instructions, QCRs, SOPs and other documents and procedures for effectiveness and modify through formal change process.
  • Perform processing steps as required in the documentation such as centrifugation, diafiltration, in-process filtration, and column separation
  • Perform final release testing
  • Perform aseptic procedures such as, filtration, filling, capping and microbial plating
  • Assist in training personnel in manufacturing procedures
  • Assist in the validation testing of equipment and processes
  • Perform assay testing for Value Assignment as required
  • Assist in new product transfer and with the development of any new procedures required
  • Assist in developing ways to increase efficiency and/or reduce costs
  • Assist with overall maintenance and cleanliness of the laboratory and equipment
  • Special projects as assigned
  • Perform additional functions as required

Education and Experience:

Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred with 1-5 years work experience in assay develoment, In Vitro diagnostics, medical device, pharmaceutical or related industry required.

Knowledge, Skills and Abilities:

  • Ability to show initiative and to perform in a multi-task environment
  • Good interpersonal and verbal/written communication skills.
  • Ability to work with personnel of all levels
  • Ability to perform in a GMP and GLP environment. Knowledge of QSR and ISO
  • Familiarity with biohazardous material handling and chemical safety procedures
  • Detail oriented.
  • Why Join Bio-Techne:
  • We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
  • We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
  • We help our employees develop their careers through mentorship, promotional opportunities, training and development, 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 foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position

Bio-Techne is an E-Verify Employer in the United States.