Senior Manager & Aseptic Manufacturing Operations

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A biopharmaceutical company in Singapore seeks a qualified individual to oversee the installation and qualification of new manufacturing equipment in aseptic processes. The role requires 8-10 years in drug product manufacturing and 3 years in a managerial capacity. Responsibilities include developing operational procedures, hiring and training staff, ensuring compliance with quality standards, and collaborating with various teams. Candidates must possess a relevant bachelor's degree and expertise in aseptic processes. A shuttle bus is provided for commuting.

Qualifications

• 8 - 10 years in drug product manufacturing experience.
• 3 years of people management experience.
• Experience in aseptic qualification and drug product manufacturing.

Responsibilities

• Support the installation and qualification of new manufacturing equipment.
• Hire, train, and manage manufacturing staff.
• Ensure adherence to quality standards for aseptic processes.
• Collaborate with Engineering and Maintenance for timely equipment validation.

Skills

Aseptic processing

People management

Interpersonal skills

Regulatory compliance

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field

Job description

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