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. The role provides custom Luminex bead-conjugation services in a controlled/regulated laboratory environment and supports customer and partner projects requiring specialized conjugation and critical-reagent expertise.

Primary Responsibilities

• 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.
• Develop and perform complex bead coupling protocols and conduct 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 analytical techniques such as FPLC, capillary electrophoresis, and BLI.
• 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 life cycle stages.
• 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.

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 with 2-3+ years of relevant experience, preferred.
• Ph.D. in Life Science with 1+ years of relevant experience, preferred.
• 2+ years experience performing protein, antibody, antigen, peptide, or other biomolecule conjugation in a GxP regulated 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 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 data-integrity requirements, required.
• Experience drafting and editing SOPs 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.
• 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 with various protein analytical techniques such as FPLC, gel electrophoresis, UV-Vis and BLI.
• 30% Domestic and International travel.