Aseptic Manufacturing Lead, NPI & Tech Transfer

WuXi Biologics; Singapore; On-site; SGD 180,000 - 260,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

People management

Leadership

Regulatory compliance

SOP development

Cross-functional collaboration

Project management

Education

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

Job description

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.