Cell Therapy Analytics Specialist - Boston MA Contract
Overview
Contract Cell Therapy Analytics Specialist leading analytical method qualification and validation for biotech clients in Boston. This 3 month role requires 40 hours weekly onsite work. Candidates must demonstrate expertise in cell therapy analytics and deliver results for late-stage clinical development and BLA submissions.
What You'll Do12
- 1Serve as technical expert supporting analytical method qualification and validation for Phase III programs
- 2Review validation data to ensure methods meet regulatory expectations and commercial readiness standards
- 3Contribute to analytical sections of regulatory submissions and health authority responses
- 4Provide technical support for flow cytometry identity characterization assays and potency measurements
- 5Assist with troubleshooting assay performance issues and implement continuous improvement initiatives
- 6Participate in analytical gap assessments to support program readiness and risk mitigation
- 7Author and revise qualification validation and transfer protocols aligned with GMP requirements
- 8Collaborate with cross-functional teams including manufacturing and regulatory affairs to execute analytical strategies
- 9Present technical findings to project teams and stakeholders throughout the development lifecycle
- 10Develop and maintain analytical methods for cell viability characterization and functional assays
- 11Support assay comparability studies across development and commercial stages
- 12Implement continuous improvement processes for analytical workflows
Requirements11
- 1Bachelor's degree with 5+ years or Master's with 3+ years or PhD with 1+ year relevant experience
- 2Proven experience with cell therapy analytical method qualification and validation
- 3Strong understanding of flow cytometry potency assays and cell viability methods
- 4Knowledge of molecular analytical techniques and GMP requirements
- 5Experience authoring validation reports and technical documentation
- 6Familiarity with assay transfer and functional cell-based analysis
- 7Background in risk assessment for analytical methods and regulatory compliance
- 8Ability to work effectively with external laboratories and CDMOs
- 9Preferred experience with BLA-enabling activities and commercial readiness
- 10Understanding of cell and gene therapy regulatory expectations
- 11Commitment to collaborative problem solving across multidisciplinary teams
Salary Insight
$75 - $110k per year
Location
Required Skills
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