CMC Data Scientist
The Data Scientist I role supports CMC analytical development for a biologics portfolio by managing and analyzing analytical data from multiple laboratory systems. Responsibilities include data trending, visualization, technical reporting, and ensuring high-quality, audit-ready documentation throughout the biologics development lifecycle. The position requires collaboration with Analytical Leads to identify trends, data gaps, and support regulatory and quality documentation in a pharmaceutical/biotech environment.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Pharmaceutical / Biotechnology.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
This contractor role supports CMC analytical development for a biologics portfolio on behalf of a confidential client. You will consolidate and validate analytical data from multiple laboratory sources, produce trend analyses and visualizations, and prepare audit-ready technical documentation to support drug substance and drug product development.
- Access, extract, reconcile, and standardize analytical results from multiple LIMS and laboratory data systems.
- Maintain analytical data repositories and tracking tools to ensure traceability and data integrity.
- Enter and manage results in approved trending tools and databases.
- Generate trend reports, dashboards, summaries, and visualizations to highlight stability, assay performance, and other CMC metrics.
- Prepare analytical data packages, Summary of Analytical Results (SARs), technical reports, and memos for Analytical Lead review.
- Present analytical findings and trend analyses to project teams and stakeholders.
- Identify data gaps or inconsistencies and support resolution with laboratory and QA teams.
- Follow GMP, data integrity, and documentation requirements to ensure deliverables are audit‑ready.
Required Qualifications
- Bachelor’s degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Biotechnology, Engineering, or a related scientific discipline.
- 1–3 years’ experience in a regulated laboratory environment (pharmaceutical, biotech, or similar).
- Hands-on experience with LIMS, electronic laboratory systems, or scientific databases.
- Strong Microsoft Excel skills (data manipulation, analysis, pivoting, reporting).
- Experience preparing technical reports, memos, analytical summaries, or quality documentation.
- Strong attention to detail with a focus on data integrity and traceability.
- Ability to manage large datasets and multiple concurrent deliverables.
- Strong written and verbal communication skills.
Preferred Qualifications
- Experience supporting CMC, analytical development, biologics, drug substance, or drug product activities.
- Experience with analytical data trending and visualization tools (dashboarding, BI tools).
- Experience integrating data from multiple laboratory systems or external testing labs.
- Knowledge of pharmaceutical development workflows, stability testing, and regulatory documentation.
- Familiarity with GMP and data integrity requirements.
- Experience with technology transfer, stability programs, or regulatory submissions.
Core Skills & Tools
- Analytical Data Management • CMC • LIMS • Data Analysis • Microsoft Excel
- Data Trending • Data Visualization • Dashboarding • Technical Writing • Analytical Development
- Biologics • Data Integrity • Scientific Databases • Technical Reporting
Logistics & Hiring Info
- Employment type: CONTRACTOR — contract term extends through May 2027 (per client requirements).
- Location: Massachusetts (MA) — the role may be performed onsite, hybrid, or remotely for candidates based in Massachusetts.
- Clearance/eligibility: Candidates must be authorized to work in the U.S. for this role.
- Background checks or other pre-employment screenings may be required by the confidential client.
- Careertakes is managing this search as a third-party recruiter; final employment terms and onboarding are set by the confidential client.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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