Description
- The Data Scientist 1 will support CMC analytical development activities for 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.
- 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.
- Experience Level: 1-3 Years.
Benefits
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.
Synectics is an equal opportunity employer.