Specialist, Analytical Science & Technology - ASAT (Contract)

Specialist, Analytical Science & Technology (ASAT), will support analytical lifecycle management activities for commercial Cell and Gene Therapy (CGT) products within the Commercial Manufacturing & Supply Chain (CMSC) organization. This role will focus on analytical data verification, trending, mining, and interpretation to support commercial manufacturing, product lifecycle management, regulatory submissions, and health authority interactions. The successful candidate will have a strong understanding of analytical testing methodologies and data analysis, with demonstrated experience supporting CTD/eCTD Module 3 documentation and regulatory submissions.

• →Lead analytical data verification, trending, and data mining activities across commercial manufacturing, stability, process validation, and product lifecycle management 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 to support internal decision-making and regulatory submissions.
• →Collaborate with Analytical Development, Quality, Manufacturing, Regulatory Affairs, MSAT, and external laboratories to collect, assess, and interpret analytical data.
• →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 analytical methods, specifications, validation summaries, stability data, comparability assessments, and post-approval changes.

• Strong understanding of analytical methods commonly used for biologics and/or cell and gene therapy products.
• Ability to critically evaluate analytical data and understand assay capabilities, limitations, variability, and performance characteristics.
• Demonstrated experience with data verification, data integrity review, trend analysis, and data mining.
• Strong technical writing with attention to detail and excellent organizational and communicational skills.
• Experience using JMP, Excel, Power BI, Spotfire, Minitab, or similar analytical and statistical tools.
• Familiarity with GMP requirements, data integrity principles, ICH guidelines, and global regulatory expectations.
• Ability to manage multiple projects and prioritize competing deadlines in a fast-paced environment.

• B.S or above in Biology, Biochemistry, Analytical Chemistry and related fields.
• Minimum 5 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.