Formulation Engineer, Drug Product Operations

Wuxi Biologics Biopharmaceuticals Singapore Private Limited; Singapore; On-site; SGD 60,000 - 96,000; Full time

Job summary

Wuxi Biologics Biopharmaceuticals Singapore Private Limited is seeking a qualified professional to support installation, qualification of manufacturing equipment and oversee key equipment packages, ensuring compliance with cGMP and client requirements in aseptic processes.

The role includes developing SOPs, master batch records, and work instructions, coordinating with Engineering, Maintenance and Validation, and readiness for extended overseas training.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• Direct experience in drug product manufacturing such as thawing and formulation, or closely related area, is preferred.
• 2+ years in drug product manufacturing.

Responsibilities

• Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.
• Support the development and implementation of operational procedures, including SOPs, master batch records, and work instructions.
• Ensure adherence to quality standards and client requirements for aseptic processes such as thawing and formulation and other processing steps as required during the initial site startup.
• Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.
• 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).
• Maintain thawing and formulation rooms and ensure adherence to stringent requirements, with flexibility for the execution during off-hours.
• Travel as necessary and be available for extended period of overseas training.

Education

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

Job description

Responsibilities:

• Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.




• Support the development and implementation of operational procedures, including SOPs, master batch records, and work instructions.




• Ensure adherence to quality standards and client requirements for aseptic processes such as thawing and formulation and other processing steps as required during the initial site startup.




• Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.




• 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).




• Maintain thawing and formulation rooms and ensure adherence to stringent requirements, with flexibility for the execution during off-hours.




• Travel as necessary and be available for extended period of overseas training.

Qualification:

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




• Direct experience in drug product manufacturing such as thawing and formulation, or closely related area, is preferred.




• 2+ years in drug product manufacturing.