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

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

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

• Seniority level:
  Director
• Employment type:
  
  Full‑time
• Job function:
  Management and Manufacturing
• Industry: Pharmaceutical Manufacturing

Durham, NC – onsite role.

• Monitor and improve manufacturing processes, including data and reports supporting regulatory compliance of drug products 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.

• M.S. degree in mechanical engineering, chemical engineering, bioengineering, or 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 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.

The salary for this position is expected to range between $ and $ annually. The final salary offered is determined based on relevant skills and experience, and will be reviewed periodically. The compensation includes a performance‑based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US‑based eligible employees receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.

Employees also have access to generous time‑off packages including vacation, personal days, holidays and other leaves.

Helping people with disease and their families takes more than innovative science. It takes a…