Job Description

Location: Preference for candidates local to Princeton, NJ or Rockville, MD . Remote considered for the right candidate (must work East Coast business hours).
Position Summary
We are seeking a Data Scientist Consultant to support analytical and stability activities for developmental, clinical, and commercial pharmaceutical products. This role will focus on ensuring compliance with GxP requirements, managing analytical data, and providing statistical insights to support regulatory submissions and business decision-making.
Key Responsibilities
Review analytical data (including raw data) for accuracy and compliance with internal and GxP requirements.
Initiate and monitor stability studies for developmental, clinical, and commercial pharmaceutical products tested by contract labs.
Review, enter, and maintain stability data for pharmaceutical products.
Create and manage studies in LIMS for multiple projects.
Enter or review sample test result data in LIMS.
Assist with technical investigations; enter deviations and investigations into Trackwise.
Maintain and manage analytical testing documentation (protocols, reports, data) in compliance with GDP and data integrity standards.
Prepare stability reports and summaries for INDs, NDAs, and regulatory submissions, ensuring accuracy and adherence to regulatory requirements.
Apply descriptive statistics to organize and summarize data.
Use statistical analysis techniques to identify patterns and trends based on project needs.
Generate graphs, profiles, and reports of testing/stability data and statistical analysis.
Collaborate with project teams to support informed business decisions through data-driven insights.
Qualifications
Required:
Bachelor’s degree in Chemistry or related science.
5+ years of experience in a GxP environment focused on analytical laboratory testing of pharmaceuticals.
Familiarity with GMP environments and analytical laboratory testing methods (HPLC, Dissolution, etc.).
Strong communication and interpersonal skills; ability to collaborate with internal and external stakeholders.
Proficiency in MS Office (Excel, Word, PowerPoint).
Demonstrated experience with data review.
Excellent oral and written communication skills.
Nice To Have
Experience with electronic document management systems (Veeva, CARA, etc.).
Experience with investigation software (Trackwise preferred).
Experience with LIMS (Laboratory Information Management Systems).
Strong planning, organizational, and coordination skills.

Job Tags

Contract work, Local area, Remote work,

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