Associate Director, Manufacturing Science & Technology – Drug Product

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 reliable production 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 formulation and aseptic fill/finish.
• Define and direct staff activities to plan, execute, and document experiments, studies, and manufacturing processes that qualify key equipment, raw materials, and processes for clinical and commercial production.
• Provide ownership and management of process, analytical, and characterization knowledge related to drug product production and the raw materials required.
• 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 biochemistry, 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 senior laboratory or operational roles within a biopharmaceutical GMP manufacturing environment, including experience with formulation and aseptic fill/finish.
• Familiarity with global cGMP manufacturing regulations for 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.