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Scientist, Product Transfer II

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Diasorin

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Location:
United States , Stillwater, Minnesota

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Category:
Research and Development

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Contract Type:
Employment contract

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Salary:

70000.00 - 86000.00 USD / Year
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Job Description:

This position is responsible for Product Transfer activities including creation of formulation documentation, implementation of quality control procedures, validation reagent formulation including quality control and support of products post launch within the LIAISON Reagents department.

Job Responsibility:

  • Work in conjunction with Product Development in creation of all documentation for LIAISON® Reagent Manufacturing and Quality Control for new products. Create part numbers for new products in the design cycle
  • Create routings for new part numbers created in design cycle
  • Aid in creation of part numbers and routings for newer team members
  • Manufacture new Internal Controls for product in the design cycle
  • Serve on Core Teams for assigned development projects
  • Perform material processing and reagent formulation for bulk intermediates and components
  • Determine reprocessing need for calibrator, controls and conjugates, with assistance
  • Maintain clean work space in QC and Reagent Prep labs, consistent with Good Laboratory Practices (GMP)
  • Contribute to group Reagent Prep and QC duties, including lab and equipment maintenance
  • Utilize basic SAP (kitting, ordering to Cost Center, assign expiration dates, etc.) to ensure correct dating, accounting and flow through facility
  • Participate in inventory accountability - PSA count, cycle counts, accurate kitting, etc.
  • Perform in-process testing and final QC for LIAISON® products per established procedures using the LIAISON® analyzer family
  • Analyze testing results of technical manufacturing, quality control or product performance to determine acceptability of product relative to established requirements
  • Assign calibrator values to optimize kit performance, with assistance
  • Assign Kit Control ranges per established procedures
  • Perform second-checking to ensure accurate records
  • Follow regulatory requirements – follow document instructions and maintain reasonable documentation error rates
  • Ensure proper documentation by correcting errors noted in procedures and forms
  • Ensure proper documentation by creating new documents and making significant revisions to current documentation for process changes, clarity or consistency
  • Perform tasks assigned in NCR / Deviations and Validations
  • Perform tasks assigned in CAPA
  • Ensure safety of self and others by complying with all company safety policies, including use of PPE
  • Participate in team meetings and attend group training sessions
  • Monitor training required in SmartTrain and ensure timely completion of all company training requirements
  • Help with basic new employee training such as instrument use, basic software training, etc.
  • Contribute to business continuity or continuous improvement projects by suggesting improvements and completing assigned tasks
  • Complete assigned tasks related to investigations for root cause determination and troubleshoot product or process issues

Requirements:

  • Bachelor’s or Master's degree in Chemistry, Biology, Medical Technology OR related science field or a 2 year degree (i.e. MLT) with equivalent experience
  • 5+ Years of related laboratory experience or demonstrated competence within the in-vitro diagnostic industry
  • Comprehensive understanding of immunology and immunoassay technology and systems
  • Ability to work in a regulated industry
  • Working knowledge of general lab equipment (e.g. pH meter, balances, mixers, etc.)
  • Knowledge of good manufacturing practices (GMP)
  • Knowledge of statistical analysis and reporting methods
  • Ability to train and mentor team members on basic group procedures and tasks
  • Ability to train and mentor team members in higher level skills
  • Proven ability to work with minimal supervision
  • Working knowledge of MS Excel
  • Familiarity with Google Suite
What we offer:
  • comprehensive plan of health benefits
  • retirement and financial wellbeing
  • time off programs
  • wellbeing support and perks
  • may be eligible to participate in an annual incentive program

Additional Information:

Job Posted:
December 28, 2025

Employment Type:
Fulltime
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