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)
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