A biomedical engineering student came to us, and wanted to get into the industry, he had no preference , just wanted a job in the biological world. We first explained the different options a BME can pursue , and narrowed it down to the biopharmaceutical world, as he had a personal aspiration of helping patients.
A targeted approach is a smart way to conduct a focused approach when interviewing, you will get similar questions. Biopharma is an interdisciplinary industry and there is room for all backgrounds. I will list out the different roles and the necessary skills.
Cell Culture Process Development: When developing protein therapeutic, it needs to be produce by living cells, the following skills are needed to propagate cells:
- Know how to work under aseptic conditions, optimize cell growth, develop cell culture media (by understanding the cell behavior and metabolite profile)
- Troubleshot early cell death phase, by investigating cytotoxic materials and find alternatives
- Scale up a research process from petri dish, to shaker flasks then stirred tank bioreactors, and understand how each phases may alter the behavior of the cells
Protein Purification Development: Characterizing the protein of interest is critical to ensure patient safety the following skills are required:
- Knowledge in Biochemistry and amino acid structures to design separation steps based on hydrophobicity, Ionic strength and molecules size
- Develop solutions (salt buffers) with the right salt concentrations that are essential for protecting the protein from denaturing during chromatography separation
- Understand the resin organic chemistry to separate out DNA, host cell protein and encapsulated viruses
Quality Control Associate: Since protein therapeutics are manufactured by living cells, ensuring product consistency is critical, and this is done by QC, skills needed:
- Microbiology techniques, such as gram staining, to ensure no contamination occurred during the process
- Serial dilution to test water quality that is used during the process
- Testing the air quality of the clean room, by particulate counting and agar plating
- Developing assays and specifications for raw material release
Manufacturing Engineer/ Associate: When the process is scaled from bench top shaker flasks to large scale stainless steel tanks and columns, associated are needed to operate them, skills needed:
- Generate procedures to run the plant in a GMP complaint way
- Troubleshot equipment failure and alarms
- Implement process improvements ideas to reduce the cost of manufacturing, and suggest new technologies to senior management
Analytical Scientist: In order to ensure the protein therapeutic is safe and efficacious, characterizing the protein is important, skills needed:
- Understand the post translation modification on the protein (glycosylation and sialyation), how that may effect immunogenicity
- Develop assays for peptide mapping and mass spectroscopy
- Operate analytical instruments such as HPLC and UPLC, as well as molecular techiniques (PCR, and SDS-PAGE)
Regulatory Affairs and Quality Assurance: Understanding the regulation during developing a therapeutic is key to get approval& marketing authorization, the following needed:
- Good documentation practices, to ensure traceability and reliability of the data
- Write sections of the CTD (Common Technical Document) which will be reviewed by global regulatory bodies
- Project management, to make sure all different disciplinaries are aligned such as (clinical development, drug product development and marketing)