Research Associate - Chemistry

Cliniqa Corporation; San Marcos (CA); On-site; USD 42,400 - 69,500; Full time

Benefits offered by this job

Competitive insurance benefits starting on day one

401(k) plans

Mentorship and promotional opportunities

Paid holidays and time off

Job summary

Cliniqa Corporation is seeking a qualified individual to develop controls and calibrators in an in-vitro diagnostics environment. Responsibilities include product development, conducting testing, maintaining laboratory equipment, and training personnel.

The ideal candidate should have a Bachelor's degree in a relevant science field and 1-3 years of experience in the diagnostics or medical device industry. Benefits include competitive insurance and opportunities for professional growth.

Qualifications

• 1-3 years work experience in In-vitro diagnostics, medical device, pharmaceutical or related industry.
• Ability to create and evaluate work instructions, SOPs and other documents.
• Knowledge of chemical and biochemical properties and handling procedures.

Responsibilities

• Develop OEM in-vitro diagnostic controls and calibrators.
• Assist in the development or optimization of new products.
• Perform final release testing on analytical instruments.
• Continually evaluate and modify work documents and procedures.

Skills

Basic troubleshooting and root cause analysis

Accurate measurement techniques

Aseptic procedures

Education

Bachelor’s degree in Chemistry, Biochemistry, Biological Science or related field

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: $42,400 - $69,500.

Position Summary: Responsible for developing controls, calibrators, working solutions, and intermediates according to approved standard operating procedures in an in-vitro diagnostics environment. 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

• Develop OEM in-vitro diagnostic controls and calibrators in areas such as Cardiac, Immunoassay, Urinalysis, Tumor Markers, Drug monitoring and Proteins.
• Assist in the development of new products or methods or optimize or refine current product lines.
• 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.
• Have basic concept of troubleshooting and root cause analysis.
• Manufacture liquid chemistry and serum-based bulks, intermediates, stock solutions, and raw materials.
• Evaluate that the analysis instrumentation and procedure is operating correctly and verify or perform maintenance and calibrations as needed 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 on analytical instruments.
• 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 with overall maintenance and cleanliness of the laboratory and equipment.
• Special projects as assigned.
• Perform additional functions as required.

Minimum Job Requirements

Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred with 1-3 years work experience in In-vitro diagnostics, medical device, pharmaceutical or related industry required.

Benefits

• Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401(k) plans, employee stock purchase plan (ESPP), Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• Mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• Employee resource groups, volunteer paid time off, employee events, and charity drives.
• Accrued leave policy with paid holidays, paid time off, and paid parental leave.
• Culture of empowerment and innovation, where employees feel valued and encouraged to bring 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.