Data Scientist I - CMC Analytical Development

Data Scientist I – CMC Analytical Development

Location: Waltham, MA – Onsite, Hybrid, or Remote
Candidate Location: Candidates located in Massachusetts or the Chicago, IL area preferred
Contract Duration: Approximately 8.5 months, through May 2027
Pay Rate: $53–$57/hour
Experience Level: 1–3 years

Position Overview

We are seeking a Data Scientist I to support CMC Analytical Development activities for a growing biologics portfolio. This role will focus on the management, analysis, trending, visualization, and documentation of analytical laboratory data supporting biologic drug development.

The Data Scientist will partner closely with Analytical Leads supporting drug substance, drug product, and analytical development activities. The position will help ensure analytical information is accurately consolidated, analyzed, interpreted, and documented to support product development, clinical advancement, stability assessments, process understanding, technology transfers, and regulatory submissions.

This is an excellent opportunity for an early-career scientist or analytical professional with pharmaceutical or biotechnology experience who enjoys working with scientific data and technical documentation.

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.

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