Bioassay Scientist I, LTG

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters
  Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture
  Thrive in a culture that values accountability, inclusion, and continuous development.

Title: Bioassay Scientist I, LTG

Job Summary

The Bioassay Scientist I will be responsible for executing and technically owning custom bead-coupling projects from conjugation approach selection through coupling, purification, characterization functional verification, stability assessment, documentation, and transfer of results to the customer. In doing so, the Bioassay Scientist will provide custom Luminex bead-conjugation services in a controlled/regulated laboratory environment. The role is responsible for executing bead-coupling workflows, including selection and application of appropriate conjugation approaches; coupling of proteins, antibodies, antigens, peptides and other molecules to Luminex beads; purification and characterization of conjugated reagents; verification of coupling performance; functional testing in multiplexed immunoassays; and documentation of results in accordance with approved procedures and applicable quality requirements.

This position supports customer and partner projects requiring specialized conjugation and critical-reagent expertise. The Bioassay Scientist I collaborates with LTG Scientific Solutions leadership and Commercial Sales, prepares technical reports, and supports field based and on-site customer training on xMAP and bead-conjugation methods, and performs assigned work in accordance with applicable GLP, or other regulated laboratory practices.

Primary Responsibility:

• Execute and document custom coupling of proteins, antibodies, antigens, peptides, nucleic acids, and other biomolecules to Luminex beads, including coupling approach, reaction optimization, purification, characterization, functional verification, and assessment against defined acceptance criteria.
• Maintain traceability of critical reagents, bead lots, conjugation materials, equipment, methods, and resulting data. Support customized conjugation of molecules to Luminex beads in a regulated environment, including testing to ensure bead quality and functionality per customer requirements.
• Responsible for developing and performing complex bead coupling protocols and conducting complex bead testing services in a regulated environment
• Perform laboratory work in accordance with approved SOPs, protocols, Good Documentation Practices, data-integrity requirements, and applicable GLP quality-system procedures.
• Conduct critical reagent characterization and stability assessment using appropriate analytical techniques (FPLC, capillary electrophoresis, BLI, and other analytical methods).
• Support change-control, corrective-action, method-qualification, equipment-qualification, and audit-readiness activities relevant to bead-conjugation services.
• Support training programs for new and existing customers on xMAP instrumentation and bead conjugation methods.
• Analyze complex experimental data using appropriate statistical methods and software.
• Communicate with Scientific Solutions leadership and commercial sales teams during project’s life cycle stages to ensure alignment with project goals, identify opportunities, optimize customer experience and support Luminex’s commercial objectives.
• Resolve moderately complex problems requiring the application of standard procedures and techniques.
• Prepare detailed reports and presentations to communicate project progress to stakeholders
• Use the approved ELN or controlled record system to maintain experimental records that are complete, contemporaneous, attributable, and traceable.
• Train and mentor junior staff in specific laboratory techniques and Good Documentation practices.
• Perform instrument calibrations/verifications as required.
• Draft and review SOPs, protocols, and project reports.
• Attend group, departmental and other necessary meetings and training sessions pertinent to work.
• Other duties as assigned

Qualifications

• Bachelor’s Degree in Life Science (Biology, Biochemistry, Immunology or related discipline) with 5-7+ years of relevant experience Required
• Master’s Degree in Life Science (Biology, Biochemistry, Immunology or related discipline) with 2-3+ years of relevant experience, Preferred
• Ph.D. in Life Science (Biology, Biochemistry, Immunology or related discipline) with 1+ years of relevant experience, preferred
• 2+ years Experience performing protein, antibody, antigen, peptide, or other biomolecule conjugation in a GxP regulated product-development, biopharmaceutical, CRO, or similarly controlled laboratory environment, required
• 2+ years Experience with both bead-based conjugations and bead-based multiplexed assays, required
• 2+ years Experience with covalent based conjugations with diverse molecules including proteins, antibodies, peptides, etc.) for multiplexed assays in a regulated environment, required
• Demonstrated experience executing work under controlled SOPs and protocols, maintaining traceable laboratory records, and complying with Good Documentation Practices and applicable data-integrity requirements, required
• Experience drafting and editing SOP’s and working instructions for a GLP or GCP compliant laboratory
• Experience with quality-system activities such as deviations, nonconformances, CAPA, change control, equipment qualification, method qualification or validation, audit support, or controlled reagent-release documentation.
• Field-based role and/or experience working directly with scientists using multiplexed assays in the field.
• Experience characterizing immunoassay critical reagents using advanced analytical instrumentation for protein analysis.
• Use of electronic notebook software in a regulated environment
• Experience working in a GLP or GCP environment
• Experience in custom conjugation of molecules to beads or other solid phase surfaces
• Ability to run multiplex immunoassays and conduct analysis of generated complex datasets.
• Proficient in protein biology, scientific principles and concepts.
• Mathematics and statistics aptitude.
• Proficient in Microsoft Word, Excel, and PowerPoint programs, Google Suite and assay data analysis software platforms.
• Ability to manage multiple projects simultaneously with proven time management and prioritization skills.
• Experience writing detailed reports and communicating project progress to stakeholders and customers.
• Excellent oral and written communication skills.
• Proficiency with ELN systems for real-time data capture, electronic signatures and audit trail management
• Proficiency with Luminex xMAP instrumentation
• Experience with biomarker assays and analysis in clinical trials
• Experience working in regulatory requirements and with quality systems (e.g., GLP, GCP)
• Experience with various protein analytical techniques such as FPLC, gel electrophoresis, UV-Vis and BLI
• 30% Domestic and International travel

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact hr@diasorin.com.

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