Aseptic processing and sterile filtration expertise
Process validation and ppq batch leadership
Simtra BioPharma Solutions partners with pharmaceutical and biotech companies to bring sterile injectable products to market with a strong emphasis on quality and continuous improvement
Job Summary
Simtra BioPharma Solutions partners with pharmaceutical and biotech companies to bring sterile injectable products to market with a strong emphasis on quality and continuous improvement.
The Senior Technical Transfer Associate leads onboarding and process development activities, collaborates with cross-functional teams, and supports manufacturing operations while ensuring compliance with regulatory standards.
Employees are eligible for comprehensive day one benefits including medical, dental, life insurance, 401(k) with company match, paid time off, and additional voluntary insurance and onsite amenities.
Matching Summary
Simtra BioPharma Solutions partners with pharmaceutical and biotech companies to bring sterile injectable products to market with a strong emphasis on quality and continuous improvement.
Skills & Requirements
Must-have
Technical transfer and process development
Aseptic processing and sterile filtration expertise
Process validation and PPQ batch leadership
Change control and CAPA management
Manufacturing floor technical support
Use of enterprise software systems
Onsite work at Bloomington facility
Nice-to-have
Cross-functional team collaboration
Mentoring and training new hires
Development and presentation of SME courses
Continuous improvement focus
High standard of quality and regulatory compliance
Key Requirements
BS degree in science or engineering
7+ years pharmaceutical manufacturing experience
3+ years technical transfer/process development experience
Advanced proficiency in Microsoft Office Suite
Experience with JDE, BPLM, Minitab, Trackwise software
Ability to qualify for Grade A/B gowning
Willingness to work overtime including nights and weekends