The biotech sector mainly includes MedTech and Biopharmaceutical companies. Biotech companies hire graduates in manufacturing, engineering (maintenance), quality, operations, Research & Development (R&D) and Supply Chain.
Are you a recent graduate looking to get into a biopharmaceutical company or medical device development company? This article will not only give you an insight into the biotech sector but also provide you information about the skill set you should possess to stay ahead of the crowd.
1.Technical Skills for Engineering and R&D positions
In a pharma company, Engineering graduates usually work on the maintenance of HVAC systems, air compressors, bioreactors, and equipment for packing, granulators etc. Usually, mechanical engineers make a good fit for these roles.
In MedTech industries, mechanical engineers with knowledge of Computer-Aided Design (CAD) and electronics engineers with the knowledge of biosensors or bioelectronic modules are often required.
2. Skills for a Quality Engineer
Quality Control is the process that allows you to check the conformity of your device or product in accordance with the desired standard. A quality engineer often analyzes the samples of a batch and ensures the conformity using a set of tools or procedures.
2.1. Quality Control Tools
Quality engineers usually have expertise in areas like Six Sigma for operational excellence, reliability analysis and risk management tools like Failure Mode and Effects Analysis (FMEA). Here are the 7 primary Quality Control tools.
- Fishbone Diagram
- Control Chart
- Pareto Chart
- Scatter Plot
2.2. Knowledge of ISO and other Standards
Some pharma companies also require the Quality Engineer to have knowledge of ISO 9001:2015. ISO 9001:2015 specifies the requirements for a Quality Management System (QMS) in an organization. This ISO standard ensures trust in customers showing that the company follows the appropriate statutory and regulatory requirements.
Watch this video to know about ISO 9001:2015:
2.3. Six Sigma
Six Sigma is a project-based approach to improve effectiveness and efficiency of an organization. The philosophy of six sigma focuses on achieving perfection.
Here are a few online courses (MOOCs) that can help you learn the skills and showcase the certification in your LinkedIn profile or CV:
3. Skills for a Manufacturing Engineer
If you are keen to work on the manufacturing and engineering side of biotech companies, you need the knowledge of ‘Good Manufacturing Practices’. The knowledge of GMP ensures excellent quality of the product manufactured.
3.1. GLP in a nutshell
Coming from academia, you may be most likely to be aware of Good Laboratory Practices (GLP). GLP is mostly used in the non-clinical setting. The GLP regulations are listed in the 21 Code of Federal Regulations (CFR) Part 58.
Some of the salient features of GLP are.
- Testing Facilities Operation: The testing facility should have a Standard Operating Procedure (SOP) for experiments so as to ensure the quality of the data generated in the studies. Preparing an SOP is not just limited to the laboratory tests. SOP can be drafted for handling test samples, preparing test samples, calibration of equipment, handling animals used in studies, data storage, and retrieval.
- Equipment handling: The equipment to be used in experiments should be located at suitable places for operation, cleaning, and inspection. SOPs should be established for cleaning, maintenance, testing, calibration, and/or standardization of equipment.
3.2. GMP in a nutshell
Contrary to GLP, GMP is most suitable for use in a clinical setting or developing products for human use as in a pharmaceutical company. GMP regulations are listed in 21 CFR Part 211. The areas which come under GMP are:
- Facilities and building
- Product process
- Equipment, tools, and machines
- Packaging and labeling
- Laboratory controls
3.3. Online Learning Resources
Here are a few online resources available to improve your skills. While the courses are free, it costs $59 to get a certification.
4. Project Management Skills
Project management skills are critical to every industry and not just the biotech sector. Knowledge of ‘Operational Excellence’ concepts can give you an edge over the competitors.
Many universities have ‘Project Management’ modules included in their curriculum. If your university doesn’t offer such a curriculum, one should focus on learning it online and pursue some online certificate courses.
The knowledge of regulatory affairs changes with the job location. However, the ISO standards, European Union Medical Device Regulation (EU MDR) and FDA regulations are followed in major parts of the world. Therefore, one needs to be acquainted with these concepts before applying for a biotech job.
The biotech sector has recorded consistent growth in all the major American, European, and Asian countries. It is growing at a rate of 10.6% in China and 7.7% globally. The global biotech market is expected to reach $775 billion by 2024, up from $390 billion in 2017. The forecasted job growth in the biotech sector is 121% from 2016 to 2026. This is the highest among all the sectors, even more than the technology, real estate, and finance sectors. In such an era of optimism surrounding the biotech sector, one must update his skills to get ahead in the career.