Manager / Senior Manager, Aseptic Manufacturing Operations

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.

• 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.

• 8 - 10 years in drug product manufacturing, with experience in aseptic processing & 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

• Strong interpersonal skills and ability to interact with clients effectively.

• Overseas Training is available

• Working Location : Tuas Biomedical Park with shuttle bus provided islandwide