Chemist - Manufacturing
Job Details
Entry
San Marcos - San Marcos, CA
Full Time
Bachelor's Degree
None
Day
Operations
Description

Where Science intersects Innovation.  By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.  CLINIQA specializes in the supply of reagents, controls, calibrators, calibration verifiers, proficiency test materials, biologicals and contract manufacturing services.

Position Summary:

Responsible for processing and formulation of controls, calibrators, working solutions, and intermediates according to approved standard operating procedures.  Responsible for manufacturing quality products on schedule.  General knowledge and basic application of concepts, theories, terminology and practices that apply to manufacturing in a laboratory environment. 

Key Responsibilities:

 

  • Prepare products using approved procedures and keep detailed and accurate records
  • Perform in process analysis 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 aliquoting, filtration, and microbial plating
  • Perform assay testing for Value Assignment as required
  • Assist in developing ways to increase efficiency and/or reduce costs
  • Assist with overall maintenance and cleanliness of the laboratory and equipment
  • Strong attention to detail, maintain clear detailed and accurate records
  • Perform additional functions as required

Knowledge, Skills and Abilities Required:

  • 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
Qualifications

Education and Experience:

Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred with 0-2 years work experience in In Vitro diagnostics, medical device, pharmaceutical or related industry required.

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

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