Manufacturing Manager/Senior, Aseptic Filling Operation (Prefilled Syringe)

You will play a key role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. This role will serve as the end user and primary point of contact for the filling area, including equipment, facilities, and supporting utilities, in preparation for aseptic manufacturing operations. This includes the development and ownership of standard operating procedures (SOPs).

You will be building and leading a high-performing team of supervisors to ensure the efficient and compliant execution of critical aseptic processes, including isolator preparation (cleaning and decontamination), aseptic filling, and plunger stoppering, while maintaining strict adherence to regulatory requirements.

In addition, the role will interface with clients and lead New Product Introduction (NPI) activities in a fast-paced startup environment, ensuring successful technology transfer, process validation, and support through product approval stages, including mock and pre-approval inspections.

Reporting to the Department Lead, Commercial DP (PFS Line)

Location : Tuas Biomedical Park with company transport provided islandwide.

Role & Responsibilities

• Support the installation and qualification of the new manufacturing equipment and own/oversee 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 cleaning and decontamination, sterilization, aseptic filling, and plunger stoppering.
• 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.
• Master in QMS production support systems such Change Control, Deviation, CAPA, and SAP.
• Accountable for the specified cleanroom environment area 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.
• Be available for extended period for training overseas.
• Interface with clients for technology transfer/NPI projects and process validation

Requirement :

• Bachelor's degree / Master's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• 8+ years in drug product manufacturing, with experience in aseptic processing and 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 plunger stoppering.
• Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
• Strong interpersonal skills and ability to interact with clients effectively.