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 Team Lead of Commercial DP for Vial Line, this position will serve as an end-user and point of contact for facility for the filling area particularly in lyophilization, and all the supporting equipment and utilities, in preparation for aseptic manufacturing operations.
You will support readiness for aseptic manufacturing operations, including ownership and development of Standard Operating Procedures (SOPs). This role ensures efficient daytoday floor operations with a strong emphasis on compliant execution of critical aseptic processes such as CIP/SIP, leak testing vial loading/unloading, and lyophilization cycles, while maintaining full adherence to regulatory standards.
Location : Tuas Biomedical Park with company shuttle bus 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.
- Train, and manage junior team members 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.
- Collaborate closely with clients and lead key activities during New Product Introduction for multiple products. This includes supporting technology transfer, process validation, and preparation for product approval processes, such as mockups and Prior Approval Inspections, in a fastpaced and dynamic environment.
- 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 team members at all times.
Requirement
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Mechanical Engineering, Biological Sciences or related field.
- Min 5 years in drug product manufacturing, with experience in aseptic processing and lyophilization related equipment and process.
- 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.
