Cell Therapy Analytics Specialist (Obsidian Therapeutics)
About The Position
Tunnell Consulting is seeking a Cell Therapy Analytics Specialist on behalf of their Pharmaceutical/Biotech clients. This is a contract position, estimated for a 3-month project, requiring 40 hours per week, all to be completed onsite in the greater Boston, MA area. The specialist will serve as a technical subject matter expert responsible for supporting analytical method qualification, validation, and lifecycle management for cell therapy products. This role involves hands-on expertise in developing, validating, and maintaining analytical methods crucial for late-stage clinical development and Biologics License Application (BLA) submissions. The specialist will collaborate with various teams including Analytical Development, Quality Control, Regulatory Affairs, Manufacturing, and external testing laboratories, contributing to analytical strategy execution, technical risk assessments, protocol development, and regulatory readiness. This position is a key technical contributor operating under the guidance of senior analytical and quality leaders.
Requirements
- Bachelor's degree with 5+ years, Master's degree with 3+ years, or PhD with 1+ years of relevant industry experience in Cell Biology, Immunology, Biotechnology, Biochemistry, or a related scientific discipline.
- Experience supporting analytical method qualification and validation for cell therapy products.
- Strong understanding of analytical requirements for late-stage clinical development and BLA submissions.
- Experience with one or more of the following: Flow cytometry, Potency assays, Cell viability and characterization methods, Functional cell-based assays, Molecular analytical techniques.
- Knowledge of GMP requirements and analytical method lifecycle management.
- Experience authoring or reviewing analytical protocols, validation reports, and technical documentation.
- Strong technical writing, data interpretation, and problem-solving skills.
Nice To Haves
- Experience supporting commercial readiness or BLA-enabling activities for cell therapy products.
- Familiarity with assay transfer and analytical comparability activities.
- Experience participating in gap assessments and risk assessments.
- Knowledge of regulatory expectations for cell and gene therapy products.
- Experience working with contract testing laboratories, CDMOs, or external analytical partners.
Responsibilities
- Serve as a technical expert in cell therapy analytical methods supporting Phase III and BLA-enabling programs.
- Support the qualification, validation, and lifecycle management of analytical methods in accordance with regulatory expectations and industry standards.
- Review and interpret validation data to ensure methods are fit-for-purpose and suitable for commercial readiness.
- Contribute to analytical sections of regulatory submissions and responses to health authority questions.
- Support assay comparability and method performance assessments across development and commercial stages.
- Provide technical support for analytical methods commonly used in cell therapy programs, including flow cytometry-based identity and characterization assays, cell viability and cell count methods, potency assays, phenotypic characterization assays, functional assays, and molecular and cell-based analytical methods.
- Assist in troubleshooting assay performance issues and implementing continuous improvements.
- Support analytical investigations and data reviews as needed.
- Participate in analytical gap assessments to support program readiness, regulatory submissions, and QC implementation.
- Contribute technical expertise to risk assessments associated with analytical methods, validation programs, and assay transfers.
- Help identify analytical risks and support development of mitigation plans and recommendations.
- Author, review, and revise qualification, validation, transfer, and comparability protocols.
- Support preparation and review of validation reports, technical summaries, and supporting documentation.
- Ensure protocols and reports align with GMP requirements, company procedures, and regulatory expectations.
- Provide technical feedback during cross-functional document reviews.
- Partner with Analytical Development, Quality Control, Manufacturing, Quality Assurance, and Regulatory Affairs teams to support program objectives.
- Collaborate with external laboratories and service providers to facilitate successful analytical activities.
- Present technical findings and recommendations to project teams and stakeholders.
Benefits
- hourly rate range is $75 - $110/hour based on experience
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What This Job Offers
Job Type
Full-time
Career Level
Senior
