Associate Director/Director, Drug Product Operations

Job Summary

The Drug Product Director, Aseptic Manufacturing (Greenfield), will play a critical role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Head of Commercial Drug Product (DP), this position will focus on facility and equipment design/selection, development and execution of operational procedures, and providing qualification support for both the facility and equipment in preparation for aseptic manufacturing operations. As the facility is currently in the design, construction, and startup phases, the immediate focus will be on leading the procurement of process equipment, contributing to the facility’s design, establishing key systems, and developing standard operating procedures (SOPs) for startup readiness. Additionally, the Drug Product Director will be responsible for building and leading a high-performing team to ensure the efficient, compliant execution of critical aseptic processes, including sterilization, formulation, filling, lyophilization, capping, and inspection, all while maintaining strict adherence to regulatory standards.

Role & Responsibilities

• Support the qualification of the new manufacturing facility and own key equipment packages.
• Develop and implement operational procedures (SOPs, master batch records, work instructions).
• Hire, train, and manage manufacturing staff to support validation and batch execution.
• Ensure adherence to quality standards and client requirements for aseptic processes such as sterilization, formulation, filling, lyophilization, capping, and inspection.
• Collaborate with Engineering and Maintenance to ensure timely calibration and validation of production equipment.
• Work with Manufacturing Science & Technology (MSAT), Validation, Quality, and QC teams to ensure procedures are developed and personnel are trained for new product introductions.
• Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction and stay up-to-date on CGMP.
• Knowledge and utilize QMS production support systems such Change Control, Deviation, CAPA, and SAP.
• Work in a cleanroom environment and ensure adherence to stringent requirements, with flexibility for overseeing executions during off-hours, if needed.
• Travel as necessary for project oversight, site visits, and training.

Qualification

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• Master’s degree or MBA is a plus.
• 15+ years in drug product manufacturing, with experience in aseptic processing.
• 10+ years of people management experience
• Direct experience in aseptic qualification (e.g., media fill simulations) and drug product manufacturing such as sterilization, formulation, filling, lyophilization, capping, and inspection.
• Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is highly desirable.
• Strong interpersonal skills and ability to interact with clients effectively.