Associate Director, Manufacturing Science & Technology – Visual Inspection, Device Assembly and Packaging

Role Summary

The Associate Director, Manufacturing Science and Technology is responsible for leading the Manufacturing Science and Technology organization at a manufacturing site to ensure consistent and visual inspection, device assembly and packaging of drug products. This role involves oversight of process improvements, regulatory compliance, and technical leadership in the production environment.

Responsibilities

• Monitor and improve manufacturing processes, including data and reports supporting regulatory compliance of drug products as they are processed through visual inspection, device assembly and packaging.
• Define and direct staff activities to plan, execute, and document experiments, studies, and manufacturing processes that qualify key equipment, incoming components, and processes for clinical and commercial production.
• Provide ownership and management of process, analytical, and characterization knowledge related to drug product inspection, device assembly and packaging and the associated inputs.
• Build and maintain a high-performing staff of engineers and scientists to support ongoing production and process transfers.
• Serve as a key scientific and technical representative for process-related issues at internal sites and with external partners.
• Partner with Manufacturing to meet production schedules, ensure commercial supply, and uphold quality standards.
• Partner with Regulatory to support product submission and approval processes.
• Perform trending and monitoring of critical quality attributes and process parameters to maintain product quality and control process drift.
• Identify and implement process improvements in collaboration with manufacturing operations.
• Review and provide feedback on project deliverables and offer technical/scientific support (e.g., remediation initiatives, reports).
• Lead investigations with Manufacturing, Quality, and other business units to determine root causes for variations, implement solutions, and ensure corrective actions are effective.
• Collaborate with other departments on manufacturing-related issues to resolve problems and support organizational goals.
• Own the process, plan to avoid delays, and lead activities to ensure a robust and effective product and manufacturing process.
• Perform other related duties as assigned.

Qualifications

• M.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related technical field, with at least 8 years of experience in pharmaceutical manufacturing; or a B.S. degree with 10 years of experience in the same field.
• Excellent oral and written communication skills.
• Experience in technical or operational roles within a GMP manufacturing environment, including experience with drug product visual inspection, device assembly and/or packaging.
• Familiarity with global cGMP manufacturing regulations for inspection, assembly and packaging of aseptic fill/finish products and associated validation/qualification requirements.
• Strong technical knowledge of associated regulatory requirements.
• Proven ability to effectively lead and participate in teams.
• May require up to 25% travel.