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Biotech/Pharmaceutical research companies usually make proteins in tiny amounts for research purposes but need to upscale and manufacture much larger quantities for bringing a new product to the market. A Production Scientist is responsible for developing and implementing the necessary systems and controls for this upstream process development to the next phase of production. The Production Scientist will need to be a detailed knowledge of good manufacturing practices (cGMP) and current good laboratory practices (cGLP) and must ensure that all manufacturing processes comply with requirements and procedures for Design Control, Risk Management and other relevant regulatory requirements (ISO 13485, QSR 820.3). The extremely stringent requirements for standards, protocols and sterility levels mean that many small biotechs and small molecule research organisations use contract manufacturing companies.
Additional tasks and responsibilities of a Production Scientist can include writing GMP manufacturing production protocols, validation, trouble shooting, maintaining lab records, writing SOPs and other Quality System documentation and compliance with Quality Assurance procedures. Excellent interpersonal and teamworking skills are also required in order to liaise with a range of key stakeholders such as Research & Development (R&D) Scientists, Process Development Scientists, Industrialisation Scientists, Process Improvement Specialists, Manufacturing Scientists, manufacturing technicians and engineers, external clients and Public Sector bodies.
Skills and Experience Required to be a Production Scientist
- BSc within Engineering or Life Sciences
- A PhD in relevant subject or courses in cGLP and cGMP
- Experience within an R&D environment
- Familiarity with good manufacturing practices (cGMP) and good laboratory practices (cGLP)
- Excellent organisational skills including attention to detail
- Communication skills and the ability to work with a wide variety of stakeholders
There is a shortage of Production Scientists as most young scientists interested in biotechnology pursue a career as research scientists. In fact, a role as a Production Scientist/ Manufacturing Scientist can be very lucrative, especially if you are prepared to work some unsocial hours or shift hours. Salaries can start in the £20k-£25k but quickly move up to £40k or more, particularly in highly technical and specialised environments.