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Rigorous routines in biotech

Open-access content 28th August 2020
Authors
Jocelyn Dorrell
Oxford Biomedica is involved in the development of a COVID vaccine – we found out more.

Image credit: Oxford Biomedica

Maintaining high standards in occupational safety and health is an ongoing challenge, even in organisations where employees engage positively and understand their individual responsibilities. But at biotech firm Oxford Biomedica, the gene and cell therapy specialists currently working to develop a vaccine to protect against the COVID-19 virus, complacency isn’t an option. The rigorous inspections that are routine in the biotechnology industry demand consistently high levels of commitment to health and safety – and the company’s staff rise to the challenge.

'The risks are actually low compared to other processing operations,' points out health and safety and biosafety adviser Lauren Crawley. But the external scrutiny of biotech firms – Oxford Biomedica is regulated by both the FDA (Food and Drug Administration) in the US and the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK – means that there are strict controls to adhere to and frequent inspections. As a result, the need to follow procedure and meet both biosafety and health and safety standards is at the forefront of everyone’s minds. Biosafety is inherent in its business to provide safe products to patients.

This commitment to high standards, together with the skills and knowledge of the people who work at Oxford Biomedica, makes gaining buy-in easier than it often is in other environments. After all, as scientists, a methodical, risk-based approach 'is their bread and butter', notes Lauren.

The pandemic forced organisations in all sectors to rethink their working practices

What hasn’t been so easy for Lauren is taking up her role at the firm just a few days before lockdown. 'I had just a week in the office,' she recalls. 'I managed to meet all of the team except one member, and then I was working from home – and I’ve never worked remotely before!'

Oxford Biomedica has around 550 employees and specialises in the development of gene-based medicines. Lauren works in a team of four advisers, each of whom has a different background and area of specialism, and alongside a Head of Responsible Business and Health and Safety.    

As part of her health and safety and biosafety adviser role, Lauren sits on the biosafety committee, which covers all areas of the business from research and development through to manufacturing. Work on genetically modified organisms, human tissue and other biological materials mean that much of Lauren’s work focuses on how biosafety relates to health and safety. 

'A significant area is waste disposal and how we treat waste,' she says. 'COSHH is another big part of my job. We can’t use the GHS [Globally Harmonised System of Classification and Labelling for Chemicals] for our COSHH assessments of biological materials, but we have a code that puts biological agents into different hazard groups. And we still have the usual risk assessments, codes of practice and procedures – as well as controlling the effects on the environment.'

With the necessity for remote working, not much of the past few months has been 'typical' for Lauren in her new job; but in any case, 'each day is different'.

'As a team, we are responsible for different areas of the business, so we all look after different groups and departments: investigating incident reports, carrying out inspections, attending group meetings and addressing concerns.

'I’ve been involved in quite a few discussions about change control in manufacturing, and HAZOP assessments. This has been quite new for me, as I haven’t been involved in the manufacturing side before. But everyone has been very welcoming.'

Over the past six months, workplaces across the country have changed, some almost beyond recognition. Remote working has become the norm in roles that would not have been considered suitable for such flexibility before the pandemic forced organisations in all sectors to rethink their working practices. For Lauren, the experience of starting a new job in lockdown has been a positive one, despite its challenges.

Looking ahead, she hopes to engage further with both the biosafety and health and safety professional communities – keeping a foot firmly in each camp.

'There’s a good biosafety community,' she confirms, 'and I’ve built up a network of colleagues in my previous roles who have lots of knowledge to share.'

On the health and safety side, Lauren completed her NEBOSH General Certificate last year; the next step, she says, is to explore networking and professional development opportunities within IOSH and beyond.

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