Data Scientist(CMC/QC)

Spectraforce Technologies

Waltham (MA)

Hybrid

USD 90,000 - 130,000

Full time

6 days ago
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Job summary

Spectraforce Technologies seeks a Data Scientist (CMC/QC) to support analytical data management, trending, visualization and technical documentation for a biologics development portfolio. You will consolidate data from multiple systems, create trend reports and dashboards, and draft high-quality CMC documents for regulatory submissions.

Requirements include a bachelor’s degree in a relevant science, 2+ years in pharma/biotech labs, strong Excel skills, and experience with LIMS or lab data

Qualifications

  • Bachelor’s degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Biotechnology, Engineering, or related field.
  • 2+ years of experience in pharmaceutical, biotechnology, or regulated lab environments.
  • Experience with LIMS or electronic laboratory systems.
  • Strong Excel skills for data manipulation and reporting.
  • Experience authoring technical reports and quality documentation.

Responsibilities

  • Access analytical data from LIMS and laboratory data management systems.
  • Consolidate analytical results into standardized templates and reports.
  • Generate trend reports, dashboards, and data summaries.
  • Prepare technical reports and SARs; ensure audit-ready documentation.
  • Support data integrity, traceability, and data package preparation.

Skills

Analytical data management
Data trending
Data visualization
Technical writing
Excel data analysis

Education

Bachelor's degree in Analytical Chemistry or related

Tools

LIMS
Electronic laboratory systems
Laboratory data databases

Job description

Job title: Data Scientist (CMC/QC)

Duration: Contract until the end of May 2027 for now.

This could be fully onsite, hybrid, or remote. Please target candidates in the Massachusetts and Chicago.

The Data Scientist 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 client's 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.

Experience Level: 1-3 Years.

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