Qc Microbiology Modernisation Lead - Barnard Castle, United Kingdom - GSK

GSK

Verified Company

Barnard Castle, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Site Name:
UK - County Durham - Barnard Castle

Posted Date:
Mar 7 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.

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
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.#LI-GSK

_ 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
Selfmotivated 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 35 years (610 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 handson 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