Manufacturing Manager/ Senior Manager, Lyophilization Drug Product Operations

Lyophilization Manager (Vial), 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 Department Lead of Commercial DP for Vial Line, this position will serve as an end-user and point of contact for both the equipment, facility for the filling area particularly in lyophilization, and all the supporting equipment and utilities, in preparation for aseptic manufacturing operations, including developing owning standard operating procedures (SOPs).

You will also be responsible for building and leading a high-performing team to ensure the efficient, compliant execution of critical aseptic processes, including CIP/SIP, leak testing, loading/unloading, lyophilization process, while maintaining strict adherence to regulatory standards. Additionally, this role will interface with clients and oversee the crucial stage and fast-paced environment of New Product Introduction of multiple new products, leading to successful tech transfer and process validation, following by supporting product approval process (Mock-up and Prior Approval Inspections).

Location : Tuas Biomedical Park (Company shuttle bus is provided islandwide)

Role & Responsibilities

• Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.
• Develop and implement operational procedures, including SOPs, master batch records, and work instructions.
• Hire, train, and manage staffs to support validation activities and batch execution.
• Ensure adherence to quality standards and client requirements for aseptic processes, particularly in lyophilization and other processing steps as required during the initial site startup.
• 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 remain up to date on current Good Manufacturing Practices (cGMP).
• Demonstrate mastery of Quality Management System (QMS) production support systems such as Change Control, Deviation, CAPA, and SAP.
• Interface with clients for technology transfer, new product introduction (NPI) projects, and process validation.
• Be accountable for the specified cleanroom environment and ensure adherence to stringent requirements.
• Be flexible to oversee execution during off-hours, if needed.
• Travel as necessary for project oversight, site visits, and be available for extended periods for overseas training.
• Maintain compliance with training requirements for self and staffs at all times.

Requirement :

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field / Master's degree or MBA is a plus.
• 10+ years in drug product manufacturing, with experience in aseptic processing and lyophilization related equipment and process. with 3+ years of people management experience
• Direct experience in aseptic qualification (e.g., media fill simulations) and drug product manufacturing such as decontamination, sterilization, aseptic filling, and lyophilization.
• Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
• Strong interpersonal skills and ability to interact with clients effectively.