Prestige BioPharma limited – CMC and Project Management Intern

Prestige BioPharma (PBP) is a Singapore based biopharmaceutical company focusing on development of biosimilars and new antibody therapeutics. PBP has strong presence and networks in Asia Pacific region and actively penetrating into the global pharmaceutical market. The successful completion of phase I clinical trial on its first biosimilar HD201 (Trastuzumab) in EU, 2014, has placed PBP amongst the top-tier biosimilar developers.

The intern will gain hands-on exposure to a broad range of CMC and Project Management activities, supporting ongoing product development, and technical assessments within the team.

• Assist with generation and formatting of tables, figures, graphs, and summaries for regulatory documentation.
• Support compilation and reconciliation of analytical and manufacturing data from multiple sources for regulatory submissions and technical reports.
• Where appropriate, assist with data trending, visualization, and analysis of large datasets to identify trends, variability, or potential areas requiring further assessment.
• Conduct literature and regulatory guideline searches to support CMC assessments and regulatory strategy development.
• Gain exposure to how CMC data are evaluated and translated into regulatory strategies and submission content.
• Support other CMC and regulatory activities or projects as assigned by the Head of Department or Management.