The Senior Scientist - Analytical progresses analytical aspects of projects, utilising their technical expertise in drug product and/or drug substance analytical development, as part of a PDS team and wider matrix teams. Conduct duties as listed below plus any other tasks as requested by team leader or departmental director. Additionally, the Senior Scientist - Analytical may perform quality control testing may approve quality control results, as applicable.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you? Basic Qualifications:
- Independently executes analytical method development and validation experiments appropriate to phase and in line with QbD approaches, based on protocols.
- Independently performs analytical work in accordance with protocols, and batch analysis requirements as appropriate, operating a range of laboratory equipment independently. Performs analytical testing and approve analytical results to support development and/or release or rejection of intermediate, bulk and finished product and/or release or rejection of starting materials, intermediates and drug substance and/or stability testing.
- May oversee contract analytical testing and approve analytical results, as applicable.
- May act as system owner for analytical equipment, as required, defining and/or organizing validation, calibration and maintenance activities and performing change control activities
- Writes specific technical sections of internal and external reports with limited supervision. Prepares brief oral or written summaries of results with interpretation and recommendation for appropriate next steps .
- May be responsible for significant aspects of analytical transfer as it relates to the drug product and/or drug substance process within/ between R&D and PSC.
- Fully understands the requirements and follows the practices related to Quality, Safety and Regulatory aspects of their work
- Complies with local data integrity requirements and may take a leadership role for data integrity projects. Attention given to data quality, integrity and archiving for own work and of others. Demonstrates timely and reliable recording of laboratory data in accordance with company policy and legal requirements.
We are looking for professionals with these required skills to achieve our goals:
- BS in Chemistry or science related degree with 5+ years of relevant experience, or MS in Chemistry or science related degree with 0+ years of science related experience
- Demonstrated technical expertise and working familiarity with several analytical techniques and laboratory procedures
If you have the following characteristics, it would be a plus:
- Knowledge of how to analyze and interpret experimental data.
- Knowledge of cGMP requirements
- Awareness with FDA/EU/UK and ICH regulations and guidance related to analytical transfer and validation and release and stability testing.
- Experience with laboratory systems (e.g. Waters Empower CDS and Labware)
- Experience with both small molecule and biopharm analytical development.
- Experience with analytical separation techniques (HPLC, uHPLC, GC, LC-MS, CGE, or cIEF )
- Strong technical writing skills for documentation.
- Excellent communication skills to collaborate well with others in the group and across groups.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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.
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