Director, Technical Services

Responsibilities

• Serve as Site Director delegate and member of the plant senior leadership team
• Lead cross-functional teams in technical transfer, commercial product support, and validation operations
• Establish and deploy validation strategies in compliance with global regulatory requirements
• Direct the development and implementation of new processes and technologies
• Manage budget development and maintenance exceeding $10MM
• Provide final approval on product/process documentation including CAPAs, deviations, and change controls
• Represent the site during regulatory inspections, client visits, and internal audits
• Collaborate with site Quality to drive improvements and risk reduction

Requirements

• Bachelor’s Degree in a technical discipline, preferably science or engineering
• Minimum 10 years of experience in aseptic manufacturing operations
• Minimum 8 years of technical management experience including cross-functional teams and budget management
• Strong knowledge of aseptic processing and validation in globally regulated industries (FDA, EMEA, PIC/S, etc.)
• Proficiency in Microsoft Office and quality enterprise software systems

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.