Senior Product Analyst – Chromatography
TypeContract
LocationUnited States
Posted2 hours ago
This is a remote position.
We are looking for an experiencedSenior Product Analystto support the successful adoption and continuous improvement of laboratory instrument data acquisition software used by hundreds of scientists across global pharmaceutical R&D laboratories.
In this role, you will bridge business, laboratory operations, quality, and IT teams to ensure laboratory software solutions are configured, validated, documented, and supported in accordance with bothGxPandnon-GxPrequirements. You will play a key role in onboarding laboratories, gathering business requirements, supporting system integrations, managing releases, and driving continuous improvements across the application landscape.
This is an excellent opportunity for someone who combines strong laboratory informatics knowledge with business analysis, stakeholder management, and regulated systems experience.
Key Responsibilities
Business Analysis & Stakeholder Management
Serve as the primary liaison between business stakeholders, Quality (QMS), and technical teams.
Lead onboarding and intake workshops for new laboratories and business groups.
Gather and document:
Laboratory workflows
Instrument processes
User roles and permissions
Data transfer requirements
Integration needs
Business use cases
Translate business requirements into application configuration and implementation plans.
Maintain stakeholder alignment, document decisions, and escalate governance issues when necessary.
Laboratory Software & Configuration
Support implementation and configuration of laboratory instrument data acquisition software.
Explain and document configuration decisions including:
Metadata structures
Custom calculations
Standards versus organization-specific configurations
Understand and document differences between GxP and non-GxP laboratory workflows.
Support application lifecycle activities and continuous improvements.
Validation & Compliance
Ensure all application activities align with organizational SDLC processes and GxP requirements.
Maintain Digital SDLC documentation for application changes and configurations.
Document:
Design decisions
Configuration rationale
Metadata standards
Validation considerations
Support audit readiness and future change requests.
Release & Change Management
Review quarterly and continuous software vendor releases.
Perform impact assessments on existing business processes.
Recommend:
Configuration updates
Adoption strategies
Business communications
Required validation activities
Testing & Quality Assurance
Develop User Acceptance Testing (UAT) and regression test scripts.
Execute and coordinate regression testing.
Support business users during testing cycles.
Ensure application changes meet quality and regulatory expectations.
User Support & Training
Provide Tier-1 application support for approximately 50 users and 50 laboratory instruments.
Escalate technical issues to appropriate technical teams.
Identify recurring support trends and improve knowledge resources.
Create and maintain:
User guides
FAQs
Training documentation
Deliver one-on-one and group training sessions for laboratory users.
Requirements
3+ years supportinglaboratory instrument data acquisition softwarewithin pharmaceutical R&D.
Experience withUnicornand/orBiacore Insightsoftware is highly desirable.
Strong understanding of laboratory workflows and scientific data management.
Experience working within bothGxPandnon-GxPlaboratory environments.
Knowledge of regulated systems including:
Audit trails
Controlled access
Validation processes
Regulatory compliance
Proven experience leading requirements gathering and onboarding workshops.
Experience producing system configuration specifications.
Experience developing and supporting User Acceptance Testing (UAT).
Hands-on experience supporting software integration projects including:
Requirements gathering
Data mapping
Stakeholder coordination
Excellent communication skills with the ability to explain technical concepts to both technical and business audiences.
Strong documentation and organizational skills.
Experience developing training materials and delivering user training.
Ability to manage multiple stakeholder requests in a complex global environment.
Nice to Have
Experience withJIRA
Experience withXrayorVera
Experience withServiceNow
Experience supporting global laboratory informatics platforms
Knowledge of SDLC documentation and computerized system validation (CSV)
Benefits
Location:Remote
Contract Type:Freelance / Contract
Start date:Summer, 2026
Time Allocation:40 hours/week
Global Pharmaceutical Company in Prague
Originally posted on Himalayas
We are looking for an experiencedSenior Product Analystto support the successful adoption and continuous improvement of laboratory instrument data acquisition software used by hundreds of scientists across global pharmaceutical R&D laboratories.
In this role, you will bridge business, laboratory operations, quality, and IT teams to ensure laboratory software solutions are configured, validated, documented, and supported in accordance with bothGxPandnon-GxPrequirements. You will play a key role in onboarding laboratories, gathering business requirements, supporting system integrations, managing releases, and driving continuous improvements across the application landscape.
This is an excellent opportunity for someone who combines strong laboratory informatics knowledge with business analysis, stakeholder management, and regulated systems experience.
Key Responsibilities
Business Analysis & Stakeholder Management
Serve as the primary liaison between business stakeholders, Quality (QMS), and technical teams.
Lead onboarding and intake workshops for new laboratories and business groups.
Gather and document:
Laboratory workflows
Instrument processes
User roles and permissions
Data transfer requirements
Integration needs
Business use cases
Translate business requirements into application configuration and implementation plans.
Maintain stakeholder alignment, document decisions, and escalate governance issues when necessary.
Laboratory Software & Configuration
Support implementation and configuration of laboratory instrument data acquisition software.
Explain and document configuration decisions including:
Metadata structures
Custom calculations
Standards versus organization-specific configurations
Understand and document differences between GxP and non-GxP laboratory workflows.
Support application lifecycle activities and continuous improvements.
Validation & Compliance
Ensure all application activities align with organizational SDLC processes and GxP requirements.
Maintain Digital SDLC documentation for application changes and configurations.
Document:
Design decisions
Configuration rationale
Metadata standards
Validation considerations
Support audit readiness and future change requests.
Release & Change Management
Review quarterly and continuous software vendor releases.
Perform impact assessments on existing business processes.
Recommend:
Configuration updates
Adoption strategies
Business communications
Required validation activities
Testing & Quality Assurance
Develop User Acceptance Testing (UAT) and regression test scripts.
Execute and coordinate regression testing.
Support business users during testing cycles.
Ensure application changes meet quality and regulatory expectations.
User Support & Training
Provide Tier-1 application support for approximately 50 users and 50 laboratory instruments.
Escalate technical issues to appropriate technical teams.
Identify recurring support trends and improve knowledge resources.
Create and maintain:
User guides
FAQs
Training documentation
Deliver one-on-one and group training sessions for laboratory users.
Requirements
3+ years supportinglaboratory instrument data acquisition softwarewithin pharmaceutical R&D.
Experience withUnicornand/orBiacore Insightsoftware is highly desirable.
Strong understanding of laboratory workflows and scientific data management.
Experience working within bothGxPandnon-GxPlaboratory environments.
Knowledge of regulated systems including:
Audit trails
Controlled access
Validation processes
Regulatory compliance
Proven experience leading requirements gathering and onboarding workshops.
Experience producing system configuration specifications.
Experience developing and supporting User Acceptance Testing (UAT).
Hands-on experience supporting software integration projects including:
Requirements gathering
Data mapping
Stakeholder coordination
Excellent communication skills with the ability to explain technical concepts to both technical and business audiences.
Strong documentation and organizational skills.
Experience developing training materials and delivering user training.
Ability to manage multiple stakeholder requests in a complex global environment.
Nice to Have
Experience withJIRA
Experience withXrayorVera
Experience withServiceNow
Experience supporting global laboratory informatics platforms
Knowledge of SDLC documentation and computerized system validation (CSV)
Benefits
Location:Remote
Contract Type:Freelance / Contract
Start date:Summer, 2026
Time Allocation:40 hours/week
Global Pharmaceutical Company in Prague
Originally posted on Himalayas
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