In this position, you 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 Department Head of Commercial DP for the Vial Line, this position will serve as an end-user and point of contact for the filling area, including its equipment, facility, supporting systems, and utilities, in preparation for aseptic manufacturing operations

Responsibilities include developing and owning standard operating procedures (SOPs). You will lead high-performing teams to ensure efficient day-to-day operations on the manufacturing floor, with a strong focus on compliant execution of critical aseptic processes. These include isolator preparation (cleaning and decontamination), aseptic filling, stoppering, lyophilization, and capping, while maintaining strict adherence to regulatory standards. Additionally, you will oversee the fast-paced and crucial stage of New Product Introduction (NPI) for multiple new products, ensuring successful technology transfer and process validation.

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

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 manufacturing staff to support validation activities and batch execution
ion.Ensure adherence to quality standards and client requirements for aseptic processes such as part washing/packaging, sterilization 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.
Be accountable for the specified cleanroom environment and ensure adherence to stringent requirements, with flexibility to oversee execution during off-hours, if needed.
Business travel as necessary for project oversight, site visits, and training.
Be available for extended periods for overseas training.
Interface with clients for technology transfer, new product introduction (NPI) projects, and process validation.

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 with 3+ years of people management experience
Direct experience in drug product manufacturing such as part preps, formulation, sterilization, and any drug product manufacturing process.
Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
Strong interpersonal skills and ability to interact with clients effectively.
Direct experience with client and regulatory audits is a plus
Experience working in multicultural and multinational environments is preferred.

Manufacturing Senior Manager, Drug Product Aseptic Filling Operation