Research and development
In an unlikely turn of events, the development of an mRNA Covid-19
vaccination boosted the profile of cell and gene therapies. But pre-Covid,
this area of life sciences was making already waves, hitting a
compound annual growth rate (CAGR) of 25.5%
since 2015.
As more products push for commercialisation, demand for specialised
professionals is ramping up. The flourishing Advanced Therapy Medicinal
Product (ATMP) landscape is carving out more roles for professionals in the
research and development field. Take a C&Q manager working within
commissioning, qualification and validation, for example, who oversees the installation, operation and performance of
equipment within a pharma facility. Working alongside a team of
commissioning engineers, CSA engineers, electrical engineers and compliance specialists, they
deliver work that is integral to the research and development phase and the
ongoing success of getting a product to market.
Bioprocessing
According to McKinsey, in June 2020, there were
750 cell and gene therapies (GCTs) at the trial stage. While Covid-19 caused major disruptions, including the pausing of site
activation, patient recruitment and missed follow-ups of patients, it has
pushed companies to seek innovative ways to make the manufacturing and
delivery model more resilient.
This is where bioprocess engineering comes into play. Put simply, ‘
a bioprocess is any process that uses living cells to create a product’. There are a number of personnel that might be involved at this stage of
product development - project managers, project engineers and senior cell
process scientists – who work together to increase the output of a
manufacturing facility by scaling up processes.
With more advanced therapies now trickling through the pipeline, from the
research stage to launch, the next challenge the industry is up against is
a shortage of skilled professionals. Reaching a bottleneck will not only
incur massive costs for CGT companies, but it also delays when patients
gain access to the products that could improve their quality of life, or in
fact, save their life. Professionals working within bioprocessing open
themselves up to attractive career prospects where they have the chance to
improve lives.
Quality assurance and quality control
Considering that the first gene therapy clinical trial started only in
1990, it’s clear that this field of life sciences has come a long way in a
relatively short time. Now regarded as one of
the most in-demand biopharma skills, cell and gene therapy expertise will take you far in the
biopharmaceutical industry. The even better news is that as some
manufacturing sectors experience declining demand, CGT companies are
opening their doors and providing cross-sectoral training to professionals
with relevant skills.
So what types of roles are available? With more products reaching the
clinical trial stage, this has bumped up the demand for quality assurance
(QA) and quality control (QC) teams. To tick the good manufacturing
practices (GMP) box, companies need to comply with quality control
standards.
As CGT is an advanced therapy, patient safety is paramount. However,
because living cells are used in the process, with limited supply, testing
to meet QC standards presents some challenges. A roster of professionals -
including QA specialists, QA managers and QAV consultants – are needed to
ensure the safety and quality of the products delivered to patients.
Take control of your life sciences career
Where can a life sciences career take you? Well at QCS Staffing, we put candidate care first, meaning that we take the time
to find out what you’re looking for in your next role.
Whether you’ve got experience in commissioning, qualification and
validation, quality assurance, pharmacovigilance, or start up projects, our
specialist consultants want to help. Browse our latest
life science vacancies, and we’ll be in touch.
