Principal Technical Transfer Representative

Simtra BioPharma Solutions

Bloomington, United States
On-site
Technical transfer documents
Process development studies
Aseptic processing
Simtra BioPharma Solutions is seeking a Principal Technical Transfer Representative to lead the technical onboarding and process development of new drug products in their Bloomington facility. The role requires extensive experience in pharmaceutical manufacturing, specifically within a Contract Development Manufacturing Organization (CDMO), and emphasizes collaboration across various functions to ensure quality and regulatory compliance

Job Summary

  • The Principal Technical Transfer Representative is responsible for the technical onboarding and process development of new drug product projects, including designing the manufacturing process(es) required for drug products.
  • This role involves leading cross-functional teams through technical activities, development studies, and PPQ batches, as well as providing technical support to daily manufacturing operations and resolving issues.
  • Key responsibilities include conducting investigations, managing change control, owning fill volume dosing qualifications, and acting as a technical representative in audits.

Matching Summary

Match Score: 85

Simtra BioPharma Solutions is seeking a Principal Technical Transfer Representative to lead the technical onboarding and process development of new drug products in their Bloomington facility. The role requires extensive experience in pharmaceutical manufacturing, specifically within a Contract Development Manufacturing Organization (CDMO), and emphasizes collaboration across various functions to ensure quality and regulatory compliance.

Skills & Requirements

Must-have

  • technical transfer documents
  • process development studies
  • aseptic processing
  • sterile filtration
  • Non-Conformance Report investigations
  • fill volume dosing qualifications

Nice-to-have

  • collaborative approach
  • continuous improvement
  • life-changing medicines
  • client calls and on-site visits

Key Requirements

  • BS degree in science or engineering
  • 6+ years pharmaceutical manufacturing experience
  • Advanced MS Office Suite proficiency
  • Experience using Enterprise software

Work Rights

Not specified

Tailored Resume

Cover Letter