Duration: 9 months contract
Summary:
- The Data Scientist 1 will support CMC analytical development activities for client's biologics portfolio by providing analytical data management, trending, visualization, and technical documentation support.
- The position collaborates with Analytical Leads supporting drug substance, drug product, and analytical development activities to ensure analytical information is accurately consolidated, trended, interpreted, and documented to support product development, clinical advancement, process understanding, stability assessments, technology transfers, and regulatory submissions.
- The contractor will access and integrate data from multiple laboratory systems, prepare analytical trend reports and presentations, generate technical reports and memoranda, and support the creation of high-quality CMC documentation required throughout the biologics development lifecycle.
Responsibilities:
Analytical Data Management
- Access analytical data from multiple LIMS and laboratory data management systems.
- Extract, organize, and reconcile analytical data from internal and external testing laboratories.
- Consolidate analytical results into standardized templates and reporting formats.
- Verify accuracy, completeness, and traceability of data records.
- Maintain data repositories and tracking tools supporting development and clinical programs.
Data Trending and Reporting
- Enter analytical results into approved trending software and databases.
- Generate trend reports, dashboards, data summaries, and visualizations.
- Compile data packages for Analytical Lead review.
- Present data summaries and trend analyses to Analytical Leads.
- Identify data gaps and support resolution activities.
Technical Writing and Documentation
- Author technical reports, memoranda, data summaries, and analytical assessments.
- Prepare and revise Summary of Analytical Results (SARs) and supporting documentation.
- Generate quality documentation using approved systems and templates.
- Support document revision cycles and response to reviewer comments.
- Ensure documentation is accurate, complete, and audit-ready.
Qualifications:
- Bachelor's degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Biotechnology, Engineering, or related scientific discipline.
- 2+ years of experience in pharmaceutical, biotechnology, or regulated laboratory environments.
- Experience working with LIMS, electronic laboratory systems, or scientific databases.
- Strong Microsoft Excel skills, including data manipulation, analysis, and reporting.
- Experience authoring technical reports, memos, or quality documentation.
- Strong attention to detail and organizational skills.
- Ability to manage large datasets and multiple concurrent deliverables.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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