Analytical Scientist, Small Molecule
Summary Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Scientist Consultant (QC/AS) to support the client's studies of developmental, clinical, and commercial pharmaceutical and related products Duties / Expectations of Role • Reviews analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance with the client's GxP requirements. • Initiate and monitor stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories. • Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceuticals and related products. • Create studies in LIMS for multiple projects • Enter or review sample test result data in LIMS • Assists in technical investigations; enters deviations and investigations into Trackwise • Maintain and manage analytical testing documentation, including protocols, reports, and data, in compliance with good documentation practices (GDP) and data integrity standards. • Prepare stability reports and summaries for inclusion in INDs, NDAs, and regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements. • Use descriptive statistical techniques to organize and summarize data • Based on project needs, use statistical analysis techniques to identify patterns and trends • Create graphs, profiles, and reports of testing and/or stability data and statistical analysis • Assist the project team in making informed business decisions based on data insights Required experience: • Master's degree in chemistry or related science + 3-5 years work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materials • Familiarity in GMP environment focused on analytical laboratory testing, including HPLC, Dissolution, etc. • Experience in data review Nice to have • Experience with electronic document management systems – Veeva, CREDO, etc. • Experience with investigation software (Trackwise preferred) Term & Start • 12-month contract - option to extend • Paid Federal Holidays for W2 • Health Insurance available Apply tot his job