Tech Transfer Senior Associate

Responsibilities

• Lead onboarding and process development for new drug product manufacture
• Create technical transfer documents including plans, studies, and batch records
• Co-lead PPQ strategy and protocol development with Process Validation
• Provide technical support to daily manufacturing operations and resolve floor issues
• Conduct Non-Conformance Report (NCR) investigations and implement CAPAs
• Manage Change Control (CCM) and impact assessments
• Act as Subject Matter Expert (SME) during regulatory, client, and internal audits
• Mentor new hires and provide guidance on Master Batch Records

Requirements

• BS degree in science or engineering related field
• 7+ years of pharmaceutical manufacturing experience
• 3+ years of Technical Transfer or Process Development experience
• Expertise in aseptic processing, sterile filtration, and Process Validation
• In-depth knowledge of mixing systems, aseptic formulations, and homogeneity testing
• Proficiency in Microsoft Office Suite and enterprise software (JDE, Minitab, Trackwise)

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.