R&D Scientiest - Process & Technical Support DP

Company Description: Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is a subsidiary of PT Kalbe Farma, Tbk., the leading healthcare provider in Indonesia and Southeast Asia. KGM is part of PT Kalbe-Genexine Biologics (KGbio) Group, which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. Job Description:

• Generate ideas, conduct tests, and develop reports on product evaluations, refining processes to improve yield and cost
• Develop secondary packaging and artwork that meets Marketing and Regulatory requirements
• Foster effective communications between teams and departments to support company needs
• Investigate production deviations, perform material qualification, and support scale-up production trials
• Carry out engineering runs, process validation, and mitigate process gaps, ensuring compliance with specifications (QTPP, CQA, etc.)
• Handle change control, investigations, corrective actions, dossier writing, and ensure proper documentation for new product releases