Director, Manufacturing Science and Technology Operations; MS&T

We are seeking an experienced Director of Technical Operations (MS&T) to provide scientific and operational leadership for a drug-product technical operations team spanning all manufacturing and packaging functions, including oral solid dosage and sterile products. This customer-focused leader will set technology transfer strategy, ensure regulatory compliance, deliver reliable processes, and drive continuous improvement across people, processes, and technology in alignment with GMP, FDA, EMA, and ICH requirements.

• Manage the end-to-end process of new product introduction and co-line evaluation
• Guide team members in reviewing new product information from R&D and coordinating cross-functional input for complex cases
• Oversee drafting of co-line evaluation reports and communicate strategies with customers

• Manage technology transfer from R&D to manufacturing for clinical-stage projects
• Allocate technical operations resources based on project needs and team capacity
• Guide batch production record development and report regularly on quality and efficiency indicators
• Lead PPQ-phase technology transfer including strategy, scheduling, documentation, and cross-functional coordination
• Monitor progress and provide regular updates to production management; organize joint reviews with R&D
• Manage all cleaning verification and validation activities including protocols, reports, sampling, and cross-functional communication
• Guide validation strategy, daily monitoring, and annual reviews; track and report execution status

• Oversee continuous process verification and annual product quality review
• Provide technical support for routine commercial production including change evaluation, deviation investigation, and process improvement
• Serve as technical lead for complex commercial manufacturing issues

• Lead customer and regulatory audit preparation, on-site responses, and post-audit corrective actions
• Support product registration activities including submission document development and supplementary responses
• Monitor evolving regulations and implement updates to internal processes as needed

• BS or MS in Pharmacy, Chemistry, or a related discipline; advanced degree preferred
• 10+ years of relevant experience in pharmaceutical production technology
• Familiarity with pharmaceutical manufacturing and cleaning processes; proficiency in lean production methods
• Approximately 20% travel required — domestic and international

• Strong hands-on leadership with the ability to guide and develop technical teams
• Deep knowledge of FDA, EMA, and ISO regulatory requirements
• Working knowledge of statistics and its practical application in pharmaceutical manufacturing
• Strong problem-solving, project management, and cross-functional coordination skills
• Proficient written and verbal communication skills in English
• Proficiency in Microsoft Office (Excel, Word, Outlook)