Profil #16505

Bavarian Nordic is a pharmaceutical company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. I worked in Process Development department, which plays a crucial role on process investigation, new process development, process validation for new products, and support on manufacturing production.

I worked primarily as a downstream scientist and also have a good knowledge and experience on upstream processes in cell culture.

Investigation and optimization of downstream and upstream process at pilot scale

Developing new processes, e.g. new TFF process, to replace the current process in production

Production process design for new products.

Scientific support on process validation for new products, including DoE study, CPP evaluation, reviewing validation report, support on engineering runs, etc.

Process upscaling from pilot to production scale. Support and training for newly implemented process at production.

Tech transfer between different sites in the company and between CMO and the company.

Process support and troubleshooting on manufacturing production, e.g. help on deviations, OOS and change control from GMP batches.

Preparation, draft review and record review of Master Batch Journal for the production of preclinical material at pilot scale.

Selection and qualification of equipment at pilot plant, e.g. TFF, Sonicator, pump, etc. Help on qualification of equipment in manufacturing.

Analysis method setup and validation in PD, e.g. SDS-PAGE, BCA, UV280, viscosity, density, DNA gel.

Close collaboration with different departments, e.g. R&D, Production, QC, QA, PM, etc.

I got thorough training on cGMP and documentation. I practiced them every day.

Our group applied LEAN in the daily work, and used several whiteboards for planning the tasks, organizing staff training, and KPI, etc.

• Writing and reviewing study plans, protocols, SOP, reports and deviations.

• Developing lipid formulation to improve oral drug delivery system
• Developing lipid quantification methods (GC, HPTLC, HPLC)
• In vitro lipolysis (Simulation of intestinal environment)
• Two peer reviewed articles were published in international journals

I joined in a project, “Enzymatic production of human milk oligosaccharides”
• Protein purification process development (Affinity chromatography, Size exclusion chromatography)
• Enzyme (sialyl-transferase) assays development by fluorescent and absorbance
• Protein characterization (SDS-PAGE, BCA, Silver staining, Western blot, etc.)