Diasorin · 14 hours ago
Process Scientist II
Stillwater, MN
Full-time
Onsite
Mid Level
$70K/yr - $80K/yr
3+ years expDiasorin is a global leader in diagnostic solutions, dedicated to improving healthcare worldwide. The Process Scientist II role involves material processing, reagent formulation, and quality control of in-vitro diagnostic products, ensuring compliance with regulatory requirements and contributing to continuous improvement projects.
BiotechnologyHealth Diagnostics
Responsibilities
Perform material processing and reagent formulation for bulk intermediates and components
Determine reprocessing needs for calibrator, controls, and conjugates
Perform Good laboratory practices - maintain clean work space in QC and Reagent Prep labs. Contribute to group Reagent Prep and QC duties, including lab and equipment maintenance
Utilize SAP (kitting, ordering to Cost Center, assign expiration dates, etc.) to ensure correct dating, accounting, and flow through facility. Additionally, create and run reports and train others on the use of SAP
Participate in inventory accountability - PSA count, cycle counts, accurate kiting, etc
Perform in-process testing and final Quality Control 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
Assign kit control ranges per established procedures
Monitor internal control supplies and manufacture new controls as needed
Assign internal controls using bias methods to ensure consistent kit performance
Perform second-checking to ensure accurate records
Perform trending of internal controls and other critical to quality specifications for assigned products to ensure proper performance of kit and controls
Follow regulatory requirements - follow document instructions and maintain reasonable documentation error rates
Ensure proper documentation by:
Correcting errors noted in procedures and forms
Ensuring 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
Write NCR / Deviations
Write and execute Validation Plans and Reports
Perform Risk Assessments
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
Help with intermediate level employee training such as more complex QC processes and assignment of controls, calibrators, etc
Contribute to business continuity or continuous improvement projects by:
Suggesting improvements and completing assigned tasks
Executing investigations where needed, defining project/scope and writing quality plans and/or validation plans
Complete assigned tasks related to investigations for root cause determination and troubleshoot product or process issues
Execute investigations for root cause determination and troubleshoot product or process issues
Qualification
Required
Bachelor's Degree or Master's degree in Chemistry, Biology, Medical Technology or related science field or a 2 year degree (i.e. MLT) with equivalent experience
3+ Years of related laboratory experience and/or demonstrated competence within the in-vitro diagnostic industry
Basic understanding of immunology and immunoassay techniques
Ability to work in a regulated environment
Working knowledge of general lab equipment (e.g. pH meter, balances, mixers, etc.)
MS Excel, familiar with Google Suite
Ability to work with minimal supervision
Knowledge of statistical analysis and reporting methods
Ability to train team members on basic group procedures and tasks
Advanced skills in mathematical and calculations, writing and documentation skills, analytical skills, and ability to grasp complex concepts and solutions
Correctable Vision (inspection work) and Ability to Distinguish Color (Label Inspection)
Benefits
Comprehensive plan of health benefits
Retirement and financial wellbeing
Time off programs
Wellbeing support and perks
Annual incentive program
Company
Diasorin
DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics
1001-5000 employees
H1B Sponsorship
Diasorin has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Doug Schuenke
CFO and VP Finance
Davide Marietta
Corporate CIO
Recent News
2026-01-23
2025-12-29
Company data provided by crunchbase