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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.

QC Microbiology Modernisation Lead

The purpose of this role is to drive implementation of new and rapid microbiology technologies to better serve our patients and the GSK pipeline. These innovative technologies will ensure data integrity, meet GSK quality standards, and support regulatory submissions and delivery of quality medicines for patients.

In This Role:

• You will design and execute method development and GMP validation for rapid mycoplasma testing using a PCR method.
• Support new and rapid microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environment (i.e., automated colony counting, automated bacterial endotoxins testing, rapid identification technology).
• Be the author and/or approve procedures, protocols, and reports and provide appropriate training in support of transferring new technologies into routine QC testing.
• Provide validation and testing data for these new methods and technologies for internal advocacy and external regulatory submission.
• Interface with R&D and external analytical sourcing groups to standardise and streamline transfer processes of new technologies into UMBL
• Apply project management (including Change Controls) and GPS tools in ways of working
• Ensure that operations are in full compliance with quality and other regulatory requirements.
• Work to GMP standards as appropriate, including participation in GMP audit programs.
• Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

Closing Date for Applications: 21st 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 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.

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Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• BS in microbiology, biochemistry, equivalent scientific or technical discipline.
• Strong project management leadership skills.
• Strong Biopharm analytical process knowledge (method, equipment, transfer processes).
• Demonstrated ability to generate options to resolve problems, prioritise solutions, determine appropriate course of action and implement the decision.
• Strong verbal and written communication skills which emphasise teamwork with a strong quality orientation
• Self-motivated with excellent verbal and written communication.
• Strong team working skills, able to work across interdisciplinary groups effectively and collaboratively.
• Strong desire to learn/scientific curiosity, with cross functional learning agility.

Preferred Qualifications/ Experience

If you have the following characteristics, it would be a plus:

• Minimum 3-5 years (6-10 yrs preferred) of industry experience.
• An understanding of the theoretical and practical aspects of Pharmaceutical Microbiology (knowledge of rapid/alternative methodologies an advantage).
• Experience with molecular techniques (i.e., qPCR and NexGen sequencing) is preferrable but not essential.
• Demonstrated hands-on and/or practical experience in microbiological analysis of pharmaceutical products, such as sterility, bioburden, microbial limits mycoplasma and bacterial endotoxins testing, and environmental monitoring.
• Capacity to think innovatively and flexibly for new microbiology methodology implementation, comfortable with complexity.
• Experience with GMP laboratory operations.
• Experience in microbiology method and equipment development and/or validation.
• Knowledge of biological and pharmaceutical product manufacturing and microbial control.
• Experience with FDA regulations.

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 organization 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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