Analytical Science and Technology Scientist - Cell and Gene Therapy
BioPharma Consulting JAD Group
Summary
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.
Job description
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.
Qualifications
- 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.
Details
- Contract: 6 months, with possible extension
- Shift: Hybrid, standard business hours (40 hours/week)
- Start: October 26, 2026
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
- Data integrity, trending and statistics
- GMP and ICH
- Strong technical writing
Company overview
BioPharma Consulting JAD Group is a specialized consulting firm operating in the biotechnology and pharmaceutical sectors. The company provides expert advisory services to biopharmaceutical companies, research institutions, and healthcare organizations. Their consulting services likely encompass strategic planning, regulatory compliance, market access strategies, clinical development optimization, and commercialization support for biotech and pharmaceutical products. As part of the JAD Group network, the firm leverages collective expertise to address complex challenges in drug development, manufacturing, and market entry. Their focus on biotechnology research suggests they work closely with emerging biotech companies to navigate the intricate landscape of drug discovery, clinical trials, and regulatory pathways. The consulting group serves as a bridge between scientific innovation and commercial success, helping clients accelerate their research and development timelines while ensuring compliance with global regulatory standards.