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 inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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 diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat isambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting 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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record