The QC Flow Cytometry Systems Scientist serves as the SME for FCS Express data analysis templates supporting GMP QC flow cytometry testing. This role designs, develops, qualifies, supports validation, maintains, and manages templates used for product release, stability, characterization, method transfer, and assay validation.
The scientist independently leads complex technical projects, makes risk-based scientific decisions, provides technical leadership for data analysis workflows, ensures compliance with regulatory and data integrity requirements, and drives improvements that enhance robustness, efficiency, and consistency of flow cytometry analysis.
The QC Flow Cytometry Systems Scientist serves as the SME for FCS Express data analysis templates supporting GMP QC flow cytometry testing. This role designs, develops, qualifies, supports validation, maintains, and manages templates used for product release, stability, characterization, method transfer, and assay validation.
The scientist independently leads complex technical projects, makes risk-based scientific decisions, provides technical leadership for data analysis workflows, ensures compliance with regulatory and data integrity requirements, and drives improvements that enhance robustness, efficiency, and consistency of flow cytometry analysis.
Duties/Responsibilities FCS Express Template Development & Configuration Independently design, build, revise, and qualify templates for all test methods including complex multi-target CAR assays; lead template program documentation and revisions; manage the full template lifecycle from design through archival
Design multi-page layout architecture; configure complex biexponential scale parameters across populations; optimize plot display for non-standard or analytically challenging datasets
Architect complete gating strategies from scratch for new test methods; define and validate all parent-child gate relationships across multi-page layouts; troubleshoot and resolve gating discrepancies across replicates and populations
Design sophisticated custom token systems including multi-condition IF/THEN/ELSE chains, nested custom token dependencies, compound N/A logic spanning multiple replicates, and dynamic batch file naming conventions; verify all formula outputs are mathematically and logically correct
Define authorization architecture across all object types for new templates; ensure design enforces data integrity and meets regulatory requirements
Develop alert frameworks for new test methods; define scientifically justified thresholds in collaboration with QC, ASAT, and method development teams
Design complete batch processing systems for new templates including folder logic, action configurations, server path structure, and dynamic file naming conventions; validate correct file export under all branching conditions
Define and assign layout-level security groups for new templates; advise QC Management on user access levels
Template Qualification & Program Ownership
Lead all qualification testing and review activities; author and maintain controlled configuration documents; serve as Business System Owner and SME for the FCS Express template program
Support regulatory inspections, internal audits, and document control activities related to FCS Express templates
Maintain expert-level knowledge across all flow cytometry method panels and marker sets; advise on FMO control strategy, atypical population analysis decisions, and statistical configuration for any flow cytometry test method
Qualifications:
Specific Knowledge/Skills/Abilities Advanced FCS Express proficiency: Ability to build and revise templates, tokens, permission rules, alerts, authorizations, and batch actions.
Formula and logic skills: Strong ability to create and troubleshoot Boolean formulas, IF/THEN/ELSE logic, nested calculations, and custom token expressions.
Flow cytometry expertise: Deep understanding of multicolor panels, compensation, FMO controls, gating hierarchy, biexponential scaling, MFI, %CV, and result reporting.
GMP qualification knowledge: Ability to define, execute, and document template qualification activities in a regulated GMP environment.
Data integrity and compliance: Strong knowledge of ALCOA, electronic records/e-signatures, audit trail review, and controlled documentation requirements.
Computerized system experience: Familiarity with validated systems, CSV concepts, user access administration, and network file management.
Technical communication: Strong written and verbal communication skills to explain technical findings to QC, QA, IT, and management stakeholders
Education/Experience/Licenses/Certifications Bachelor?s degree in biology or related scientific discipline with 6 years of GMP experience, or equivalent combination of education and experience.
Demonstrated expertise in flow cytometry analysis, assay lifecycle management, and complex technical problem solving.
Demonstrated experience in FCS Express template creation and/or revision strongly preferred
Experience leading cross-functional projects and influencing scientific decisions.
Strong understanding of qualification, validation, and computerized system lifecycle principles.
Collaboration & Communication Serve as technical resource on FCS Express template development, troubleshooting, and GMP documentation
Collaborate with flow cytometry SMEs on test method requirements that drive template design decisions
Partner with IT on FCS Express software maintenance, user access management, and template file administration
Engage QA/Compliance as needed for escalation of audit trail discrepancies or deviations identified during template qualification or data review
Reporting Relationship This position will report to QC management.
100% Onsite! M-F; Standard Hours! This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.
The starting hourly compensation for this assignment is the following range ($68- $72.54/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.
About ASK Consulting ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.
Benefits:
ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.
Equal Opportunity Employer ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.
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