BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

Analytical Science and Technology Scientist - Cell and Gene Therapy

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBoston, MA, USANo salary listed

About the Job

Requirements

A bachelor's degree or higher in Biology, Biochemistry, Analytical Chemistry, or a related field is required.
At least five years of experience in pharma or biopharma is required, including analytical methods for biologics or cell and gene therapy.
Experience authoring or reviewing CTD/eCTD Module 3 content is required.
Knowledge of data integrity, trending, statistics, GMP, and ICH is required.
Strong technical writing skills are required.

Responsibilities

Lead analytical data verification, trending, and data mining across manufacturing, stability, and validation.
Investigate anomalies and build statistical analyses and visualizations using JMP, Spotfire, and Power BI.
Author technical reports, scientific justifications, and CTD/eCTD Module 3 sections.
Partner with Analytical Development, QA, Regulatory, MSAT, and external laboratories.

Analytical Science and Technology Scientist - Cell and Gene Therapy

BioPharma Consulting JAD Group · Boston, United States (Hybrid) · Contract · Posted 2026-10-24

Workplace: hybrid

Department: Vertex

Description

Turn analytical data into decisions for commercial cell and gene therapy products at a leading biotechnology company in Boston, Massachusetts. You will verify, trend and interpret analytical data, then author the CTD Module 3 content that supports regulatory submissions.

What you'll do

Lead analytical data verification, trending and data mining across manufacturing, stability and validation.
Investigate anomalies; build statistical analyses and visualizations (JMP, Spotfire, Power BI).
Author technical reports, scientific justifications and CTD/eCTD Module 3 sections.
Partner with Analytical Development, QA, Regulatory, MSAT and external labs.

Requirements

Bachelor's degree or higher in Biology, Biochemistry, Analytical Chemistry or related.
5+ years in pharma/biopharma; analytical methods for biologics or cell and gene therapy.
CTD/eCTD Module 3 authoring or review (required).
Data integrity, trending and statistics; GMP and ICH; strong technical writing.

Benefits

Contract: 6 months (November 16, 2026 – May 14, 2027), with possible extension
Shift: Hybrid, standard business hours (40 hours/week)

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About the Company

BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

BioPharma Consulting JAD Group advises pharmaceutical and biotechnology businesses on engineering, quality and regulatory compliance. It works with companies operating under US Food and Drug Administration rules to develop technical solutions for their manufacturing plants and processes. Its engineering practice covers facility and equipment design, process improvements and project management, while validation work verifies and documents that production systems meet requirements. The firm sells tailored consulting and technical support for assignments and projects, with company managers involved in delivery. Founded in 2010, it is headquartered in Cambridge, Massachusetts.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Cambridge, MA
Founded: 2010

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