WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical.
Role & Responsibilities
- Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.
- Develop and implement visual inspection program and procedures, including SOPs, master batch records, and work instructions.
- Hire, train, and manage visual inspection staffs to support validation activities and batch execution.
- Ensure adherence to quality standards and client requirements for visual inspection using fully automatic, semi-automatic and manual inspection processes.
- 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 visual inspection and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP).
- Demonstrate mastery of Quality Management System (QMS) production support systems such as Change Control, Deviation, CAPA, and SAP.
- Interface with clients for technology transfer and new product introduction (NPI) projects.
- Be accountable for the specified visual inspection areas 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.
Education
- Bachelor’s degree / Master Degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
- 8 - 10 years in drug product manufacturing, with experience in visual inspection with 3 years of people management experience
- Direct experience in drug product manufacturing, particularly in building and managing visual inspection process and program.
- Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
- Strong interpersonal skills and ability to interact with clients effectively.
- Location : Tuas Biomedical Park (with company transport provided islandwide)