| (01) |
Animal
Cell culturing (cell suspension or/and adherent)
- cell banking, cell sorting/screening, serum
free adaptation, spinner bioreactors, viral induction,
anti-viral assays, Flow Cytometry, cell culture
lab management. |
| (02) |
Protein Over-expression in Human Cells– viral
or non-viral vector construction and maximization
for mammalian systems, RNAi technique, transfection
and transformation, quantification techniques
for gene expression; High-Through-Put Screening. |
| (03) |
Biochemical
Engineering–operation and optimization for small-,
pilot- or industrial scales of bioreactors (including
roller bottles or cell factories) for animal cell
cultures, knowing process design is preferred;
large cell culture concentration and recovery
techniques. |
| (04) |
Protein Purification – must be familiar with various
column chromatography techniques for FPLC and
HPLC; knowing process design for purifying new
protein targets is preferred. |
| (05) |
Protein Assays – development for in-house qualification
and quantification assays using (A) immuno-techniques
such as ELISA etc., (B) HPLC profiling and LC-Mass
(-Mass) techniques. |
| (06) |
Protein Drugs Formulation – must know the FDA
regulation to generate legally accepted formulations
for protein drug storage and for stability evaluation. |
| (07) |
Animal Toxicity –with experience of conducting
/ coordinating GLP level pre-clinical pharmacology
/ toxicology studies such as genotoxicity, acute
toxicity, chronic toxicity, pharmacokinetic studies
and pharmacology studies etc. |
| (08) |
Clinical Research –with experience of conducting
/ coordinating ICH-GCP standard clinical studies.
Experience in early phase studies (phase I or
phase I/II) is preferred. |
| (09) |
QA/QC –with experience of performing quality assurance
/ quality control in pharmaceutical industry.
Good at document management and SOP writing /
maintenance. |
| (10) |
Regulatory Affairs – must be familiar with FDA
regulations of biological products and medical
devices, 2 years experience with good communication
skill in English is preferred. |