Principal Manufacturing Science and Technology (MSAT) Representative

Responsibilities

• Lead onboarding and process development for new drug product manufacturing
• Serve as the lead technical expert within cross-functional teams
• Create technical transfer documents including Tech Transfer Plans and PPQ master batch records
• Provide technical support to daily manufacturing operations and resolve floor issues
• Conduct Non-Conformance Report (NCR) investigations and implement CAPAs
• Manage Change Control Management (CCM) and impact assessments
• Act as a technical representative during regulatory, client, and internal audits
• Mentor new hires and provide guidance to junior colleagues

Requirements

• BS degree in a science or engineering related field
• 6+ years of pharmaceutical manufacturing experience, preferably in a CDMO
• In-depth knowledge of aseptic formulations, sterile filtration, and process validation
• Expertise in mixing systems, fill volume limit setting, and homogeneity testing
• Advanced proficiency in MS Office Suite
• Experience with enterprise software such as JDE, BPLM, Minitab, or Trackwise
• Ability to qualify for Grade A/B area gowning

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) specializing in sterile injectable products, including biologics, small molecules, and vaccines.