Cell Therapy Analytics Specialist — BLA-Ready Methods

Tunnell Consulting; Cambridge (MA); On-site; USD 103,000 - 152,000; Full time

Job summary

Tunnell Consulting is seeking a Cell Therapy Analytics Specialist for a 3-month contract in the greater Boston area. The role is onsite with a 40-hour week, focusing on analytical method qualification, validation, and lifecycle management for cell therapy products.

Ideal candidates have 5+ years in related fields, strong GMP knowledge, and experience supporting BLA submissions. Local candidates preferred as onsite work is required.

Qualifications

• Bachelor’s degree with 5+ years in cell biology, immunology, biotech or related field.
• Experience supporting analytical method qualification and validation for cell therapy products.
• Strong understanding of regulatory expectations for late-stage development and BLA submissions.

Responsibilities

• Serve as a technical expert for cell therapy analytical methods supporting late-stage programs.
• Assist in qualification, validation, and lifecycle management of analytical methods.
• Prepare and review validation reports, protocols, and technical summaries.
• Collaborate with cross-functional teams to support regulatory submissions and readiness.

Skills

Flow cytometry

Potency assays

Cell viability

Functional assays

Molecular analytics

GMP

Protocols writing

Education

Bachelor’s degree in Cell Biology/Immunology/Biotechnology

Master’s degree in related field

PhD in related field

Job description

Tunnell Consulting is seeking a Cell Therapy Analytics Specialist for a 3-month contract in the greater Boston area. The role is onsite with a 40-hour week, focusing on analytical method qualification, validation, and lifecycle management for cell therapy products.

Ideal candidates have 5+ years in related fields, strong GMP knowledge, and experience supporting BLA submissions. Local candidates preferred as onsite work is required.