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

WuXi Biologics; Singapore; Vor Ort; SGD 180.000 - 260.000; Vollzeit

Zusammenfassung

WuXi Biologics in Singapore seeks a senior leader to support the startup of an aseptic manufacturing facility in Tuas Biomedical Park. You will own the filling area, including equipment, facilities and supporting utilities, and develop SOPs.

You will build and lead a high-performing team of supervisors to ensure the efficient execution of aseptic processes, drive NPI and technology transfer, and ensure compliance through product approvals and inspections.

Qualifikationen

• 8+ years in drug product manufacturing.
• Experience in aseptic processing.
• 3+ years of people management experience.
• Experience in fast-paced CDMO environments is desirable.

Aufgaben

• Support installation and qualification of new manufacturing equipment and oversee key equipment packages.
• Develop and implement SOPs, master batch records, and 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 (cleaning, decontamination, sterilization, aseptic filling, plunger stoppering).
• Collaborate with Engineering/Maintenance to ensure calibration and validation of production equipment.
• Coordinate with MSAT, Validation, Quality, and QC for new product introductions and process validation.

Kenntnisse

People management

Leadership

Regulatory compliance

SOP development

Cross-functional collaboration

Project management

Ausbildung

Bachelor's or Master's in Pharmaceutical Sciences or related field

Jobbeschreibung

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.