The Job 

• Provide guidance and hands-on assistance with biochemistry and molecular biology assays, including: column chromatography, proteomics techniques, PCR methods (extraction of residual DNA, primer design, quantitative PCR), mass spectrometric techniques and immunoassays etc.
• Plan, execute and interpret experiments on protein drug development and formulation.
• Lead a team in drug product development and quality enhancement function on formulation and process development projects in a cross function matrix team environment.
• Coordinate analytical support for formulation and process development as well as quality enhancement.
• Maintain proficiency in the biological drug development process including a thorough understanding of the molecular attributes, target quality profiles and linking them to patient safety and efficacy aspects.
• Provide analytical expertise and knowledge of biopharmaceutical development process to support and drive analytical CMC activities.
• Plan and prepare CMC documentations for CTA submissions and amendments. 

The Person

• PhD in Biology, Biochemistry, Biotechnology or equivalent discipline with minimum of 3 years experience in Biological Drug Development.
• Strong knowledge of Biochemical principles, Chromatography, Protein Chemistry and Immunoassays.
• Experience in drug substance and drug product manufacturing as well as method development, characterization and technology transfer preferred.
• Adequate knowledge of US, Canada and EU CMC regulations as well as ICH guidance documents related to CMC matters and strong knowledge of process, formulation or analytical chemistry for biologic products.
• Strong organizational, leadership, and managerial skills.
• Excellent trouble-shooting capabilities.
• Experience resolving analytical technical issues.
• Strong interpersonal and written and oral communication skills.
• Travelling to PRC and oversea as stationing for a short period may be required.

We offer attractive remuneration and benefits, 5 days per week, annual leave, medical scheme, comprehensive training and career development opportunities to the qualified candidates.

Please send your application with full resume stating your present and expected salary to the Company by clicking on the "Apply now" or by following methods. Please quote the reference number of the applied position in the subject field.

• Mail: Human Resources Department, New β Innovation Limited, 18 Chevalier Commercial Centre, 8 Wang Hoi Road, Kowloon Bay, Kowloon, Hong Kong

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