Site Name: UK – Hertfordshire – Stevenage
Posted Date: Oct 22 2021
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer.
We’re seeking a motivated experienced analytical chemist to join our Drug Substance and Product Analysis teams at GSK’s flagship R&D site in Stevenage. As a member of a team you will lead analytical aspects aligned to the development, manufacture and supply of new small molecule drug substances.
Your role will be office and laboratory based. You will contribute to the development of the analytical control strategy for new drug substances, author key analytical documentation including methods and specifications, design and execute method development, validation and transfer experiments, author sections of regulatory submissions and develop responses to regulatory questions. You will deliver some of these tasks independently and may lead small teams to deliver others.
The successful applicant can expect excellent onward training in analytical development as well as the opportunity to collaborate with experts working in other disciplines; particularly formulation, manufacturing, regulatory and synthetic chemistry.
- Lead the transfer of methods to commercial manufacturing sites
- Author sections of regulatory submissions and develop responses to regulatory questions
- Contribute to the development of the analytical control strategy for new drug substances
- Executing analytical work safely in accordance with GMP
- Apply analytical techniques including; HPLC, GC, KF and spectroscopic techniques which will cover projects right across the development cycle from first time in human through to commercialisation
- Working in a matrix team to ensure appropriate analytical methods are in place as required for the assessment of intermediates and drug substance and their release for clinical use
- Clearly report the results of your experiments and communicate the results and your conclusions to matrix teams and management
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.
We are looking for professionals with these required skills to achieve our goals:
- BSc/MChem (or equivalent) in a relevant discipline
- Previous experience of analytical techniques including; HPLC, GC, KF and spectroscopic techniques
- Knowledge of ICH quality guidelines and their applicability to small molecule drug substance
- GMP knowledge / experience
- Knowledge of the requirement for releasing drug substances for clinical studies
- Excellent written and oral communication skills
If you have the following characteristics, it would be a plus:
- PhD (or equivalent) in a relevant discipline
- Previous experience authoring regulatory submissions (eg. IND, CTA, MAA, NDA)
- Previous experience in the development of the analytical control strategy for new drug substances
Closing Date for Applications: 3rd November 2021
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
At GSK, we’re a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.
When you set out on your adventure at GSK, we make a deal. You commit to living GSK’s values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it’s about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.
Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please contact your local HR department.
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.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
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 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.
Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
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.
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 site.
This employer is a corporate member of myGwork, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.
Apply For This Job
You can apply for this job externally via the button below.Apply for this job externally