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Analytical Science and Technology Scientist
BioPharma Consulting JAD Group. Lead analytical data verification, trending and data mining across commercial manufacturing, stability, process validation and lifecycle programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical data verification, trend analysis, and regulatory documentation within the pharmaceutical industry, with a strong focus on biologics and cell and gene therapy products. Proficient in utilizing statistical tools for data analysis and visualization while ensuring compliance with GMP and ICH guidelines.
Highest-signal resume keywords
Analytical Methods For BiologicsCTD/eCTD Module 3 DocumentationData Verification And Integrity ReviewStatistical Analysis Using JMPTechnical Writing And Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Data MiningTrend AnalysisStatistical AnalysisAnalytical Data VerificationRegulatory Submissions Support
Soft Skills
Organization SkillsCommunication Skills
Tools & Technologies
JMPExcelPower BISpotfireMinitab
Industry Keywords
Pharmaceutical IndustryBiopharmaceutical IndustryGMPData Integrity PrinciplesICH Guidelines
About the role
Key responsibilities & impact- Lead analytical data verification, trending and data mining across commercial manufacturing, stability, process validation and lifecycle programs
- Compile, review and analyze analytical datasets to identify trends, investigate anomalies and support scientific conclusions
- Generate statistical analyses, data visualizations, summaries and technical assessments
- Collaborate with Analytical Development, Quality, Manufacturing, Regulatory Affairs, MSAT and external laboratories
- Author and review technical reports, data summaries, scientific justifications and regulatory support documents
- Support preparation, review and lifecycle maintenance of CTD/eCTD Module 3 content, including methods, specifications, validation summaries, stability, comparability and post-approval changes
Requirements
What you’ll need- B.S. or above in Biology, Biochemistry, Analytical Chemistry or related field
- Minimum 5 years of pharmaceutical/biopharmaceutical industry experience
- Strong understanding of analytical methods for biologics and/or cell and gene therapy products
- Experience with data verification, data integrity review, trend analysis and data mining
- Experience supporting CTD/eCTD Module 3 documentation and regulatory submissions
- Proficiency with JMP, Excel, Power BI, Spotfire, Minitab or similar statistical tools
- Familiarity with GMP, data integrity principles, ICH guidelines and global regulatory expectations
- Strong technical writing, organization and communication skills
Benefits
Comp & perks- Contract position: approximately 6 months (October 2026 – April 2027), with possible extension
- Standard business hours, 40 hours/week
- Hybrid work arrangement in Boston, Massachusetts