Full Time Manufacturing Manager (Drug Substance) Jobs, in WuXi XDC - Maukerja

Location: Tuas Biomedical Park

Job Responsibilities:

1. Manufacturing Operations & Process Execution

• Ensure manufacturing operations are conducted in strict compliance with SOPs and MBR requirements, with all activities completed according to plan and all documentation recorded accurately and timely.
• Perform and oversee drug conjugation reactions, purification, weighing, sampling, and sample management activities.
• Operate and supervise equipment related to conjugation and purification processes to ensure safe and efficient execution.

2. Equipment Qualification & Facility Management

• Take responsibility for FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and IOPQ (Installation, Operational, and Performance Qualification) activities.
• Oversee workshop and facility maintenance to ensure production equipment and utilities are operating as intended and compliant with GMP requirements.

3. Quality, Compliance & Documentation

• Draft, review, and maintain SOPs and other relevant process documentation in accordance with leadership direction.
• Support and lead activities related to deviations, change controls, audits, and other quality system requirements.
• Act as a key contributor during internal and external audits and inspections, leading preparation and on-site responses as required.
• Proficient in the use of quality and manufacturing systems, including TrackWise, MasterControl (full license), GAIA, and other applicable electronic systems.

4. Leadership & Shift Management

• Assume responsibilities of Shift Leader and Co-FL, ensuring smooth operation during assigned shifts.
• Act as supervisor delegate in the absence of the Director, maintaining operational continuity and team accountability.
• Lead and manage the team to ensure efficient daily operations, including leave applications, overtime approval, and resource coordination.
• Ensure all team members complete required training and qualification activities in a timely manner in accordance with GMP and company requirements.
• Represent the team in communications with internal and external stakeholders, ensuring clear alignment on operational and compliance matters.

5. Other Responsibilities

• Perform other ad-hoc or interim tasks as assigned by leadership to support business and operational needs.

Requirements:

• Bachelor’s degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, or a related discipline.
• Minimum of 8 years of hands-on experience in biopharmaceutical manufacturing and at least 3 years of experience in team leadership and operational management.
• Familiar with GMP requirements and regulatory standards, including HSA, FDA, China NMPA, EU, and ICH guidelines.
• Solid understanding of sterile pharmaceutical manufacturing and pharmaceutical quality systems.
• Experience with ADC and/or CMO manufacturing systems is preferred.
• Familiar with Single-Use Technologies (SUT) in biopharmaceutical manufacturing.
• Familiar with downstream processing and/or bioconjugation manufacturing.
• Able to commit for shifts hours