Technical Transfer Lead

Element Staffing Services; United States; Hybrid; USD 140,000 - 190,000; Full time

Job summary

Element Staffing is seeking a Sr. Analytical Development Scientist / Tech Transfer Project Manager (TTPM) to lead analytical method transfers for sterile injectables.

You will bridge R&D, QC, and CMOs, guiding method development, validation, and regulatory support to ensure compliant, robust product transfer. The role requires 5+ years in pharma with emphasis on Tech Transfer, Lyophilization, and complex dosage forms.

Qualifications

• 5+ years in the pharmaceutical industry with heavy Tech Transfer/focus on Sterile Injectables and Lyophilization.
• Experience with method development & validation and regulatory support.

Responsibilities

• Lead analytical method transfers from R&D to commercial manufacturing sites.
• Provide technical documentation and risk assessments for transfers.
• Oversee CMO interactions and investigations during transfers.
• Support CMC submissions with technical data and narrative sections.
• Ensure methods meet USP/EP and ICH guidelines.
• Troubleshoot method discrepancies during site-to-site transfers.

Skills

Method Transfer Leadership

Tech Transfer

HPLC

GC

Pharmaceutical Analysis

Lyophilization

Quality Control

Education

Bachelor’s or Master’s in Chemistry or Pharmaceutical Sciences

Tools

LIMS

Empower

Chromeleon

Job description

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 that works entirely with sterile injectibles. 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.

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 heavy focus on Tech Transfer, Sterile Injectables, and Lyo processing; method development & validation, filter selection, and internal/external technical meeting experience a plus.
• 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.