Description

Key Responsibilities

• Access and manage analytical data from LIMS, laboratory data management systems, and other scientific databases.
• Extract, organize, reconcile, and consolidate analytical results from internal and external testing laboratories.
• Verify analytical data for accuracy, completeness, consistency, and traceability.
• Maintain data repositories, tracking tools, and standardized reporting templates supporting development and clinical programs.
• Enter analytical results into approved trending software and databases.
• Generate analytical trend reports, dashboards, data summaries, and visualizations.
• Compile data packages and present analytical summaries to Analytical Leads.
• Identify data gaps, inconsistencies, and trends and assist with resolution activities.
• Author and revise technical reports, memoranda, analytical assessments, and data summaries.
• Prepare and revise Summary of Analytical Results (SARs) and supporting documentation.
• Support document review and revision cycles, including responses to reviewer comments.
• Ensure technical documentation is accurate, complete, traceable, and audit-ready.
• Collaborate with cross-functional CMC and Analytical Development teams throughout the biologics development lifecycle.

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Biotechnology, Engineering, or a related scientific discipline.
• 1–3+ years of experience within a pharmaceutical, biotechnology, biologics, or regulated laboratory environment.
• Experience working with LIMS, electronic laboratory systems, scientific databases, or laboratory analytical data.
• Strong Microsoft Excel skills with experience manipulating, organizing, analyzing, and reporting scientific data.
• Experience with data trending, visualization, and preparation of analytical summaries.
• Experience authoring technical reports, scientific memoranda, analytical summaries, or quality documentation.
• Ability to work with large datasets while maintaining strong attention to detail and data integrity.
• Strong organizational and communication skills with the ability to manage multiple concurrent deliverables.

Preferred Qualifications

• Experience supporting CMC, Analytical Development, Quality Control, or biologics development.
• Experience working with drug substance or drug product analytical data.
• Familiarity with analytical testing, stability data, method development, or pharmaceutical development.
• Experience preparing documentation supporting regulatory or development activities

Key Skills

Education

Bachelor's degree