Job description
Posted Date: Feb 23 2023
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 million vaccine doses in 2021.
We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.
Quality Control Bioassay Analyst
GSK are recruiting for a Quality Control Bioassay Analyst to join them on a full-time and permanent basis at the site based in Stevenage. There may be some flexibility of working from home in this role when business permits.
You will gain exposure to working in the biopharmaceuticals industry where you will work cross functionally within BioCTL department and gaining experience of new techniques such as cell-based potency assays and Surface Plasmon Resonance assays.
You will be working with an established and experienced team and there will be fantastic opportunity for development and career progression.
Job Purpose
The Job holder is responsible for the routine Bioassay/Immunoassay testing of In-process, Drug Substance, Drug Product, and stability samples for internally and externally manufactured Biopharm products.
In this role you will…
- Test samples utilising a range of biochemical and biological tests, in accordance with regulatory requirements and agreed schedules. Maintain the working cell bank to utilise into Bioassay/Immunoassays.
- Provide information on biochemical methods, test specifications and sampling regimes, and the impact they may have on the product.
- Maintain detailed laboratory records in accordance with current Good Manufacturing Practice (cGMP) through the use of controlled pro forma or laboratory notebooks.
- Ensure that all records and test results are accurately prepared and checked, peer reviewed prior to submission for approval for authorisation and according to company, customer and regulatory requirements.
- Record deviations from the normal practice and out of specification results appropriately and report them to the line manager; assist with investigations product and test anomalies.
- Deliver and assess formal training programmes for staff and trainees as required.
- Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance.
- Facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory and responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures.
- Write, review and update SOPs and associated pro-forma used within the laboratory, prepare draft method of analysis and SOPs when new techniques are introduced in the area
- Participate in the validation of test methods and equipment used in analysis to meet regulatory requirements.
Closing Date for Applications: Thursday 9th March 2023
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Why you?
Basic Qualifications:
- BSc in Biochemistry, Microbiology, Biology, or Chemistry
- Has knowledge and understanding of biochemical techniques and analytical disciplines aligned to bioassays
- Ability to troubleshoot and develop assays.
- Computer literate and competent in the use of corporate IT systems and Microsoft packages.
Preferred Qualifications:
- Biopharmaceutical product release experience
- Has an understanding of working to GMP and GLP compliance
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Find out more:
Annual Report 2021
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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