Tech Transfer Lead, Sterile Injectables & Analytics

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

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.