Senior Analytical Development Scientist (San Diego)

Job Title: Sr. Analytical Development Scientist / Tech Transfer Project Manager (TTPM) Job Description: Element Staffing is recruiting for a Tech Transfer Specialist with a heavy emphasis on Analytical Method Transfer for a high-growth pharmaceutical company based in San Diego. This is a fantastic opportunity to serve as the critical technical bridge between R&D, Quality Control, and external Contract Manufacturing Organizations (CMOs).

The Analytical Lead will ensure that complex analytical methods for sterile injectable products are successfully validated and implemented to support a robust pipeline of life-saving medicines. Local candidates only. Duties/Responsibilities/Qualifications:Method Transfer Leadership: Lead the technical transfer of analytical methods (HPLC, GC, Particle Matter, Karl Fischer, etc.) from R&D to commercial manufacturing sites.

Specialized Product Oversight: Provide technical expertise for complex dosage forms, including lyophilized products, pre-filled syringes (PFS), and sterile injectables. Technical Documentation: Author and review Analytical Method Transfer Protocols, Validation/Verification plans, and Quality Risk Assessments. CMO Management: Act as the primary analytical point of contact for external partners; oversee OOS (Out of Specification) investigations and troubleshoot deviations during transfer phases.

Regulatory Support: Provide technical data and narrative sections for CMC (Chemistry, Manufacturing, and Controls) submissions, including ANDA/NDA filings. Method Validation: Ensure all methods meet USP/EP compendial testing standards and ICH guidelines. Troubleshooting: Resolve method discrepancies during site-to-site transfers through detailed data analysis and detective work.

Additional Information: Years of Experience: 5+ years in the pharmaceutical industry with a focus on Analytical Development or Tech Transfer. Education: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field. Shift/Travel: Standard business hours with Hybrid/Remote flexibility based on project needs.

Requirements: Mastery of ICH guidelines; proficiency in LIMS and Chromatography Data Systems (Empower/Chromeleon). Proven experience with Injectables or Lyophilized products is required. Preferred Skills: Knowledge of Pre-filled Syringes (PFS), E&L (Extractables & Leachables) testing and moisture analysis for freeze-dried products.

Compensation: $48-75/hr DOE Location: San Diego, CA