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Scientific Leader - Extractables and Leachables (E&L)

GSK, Stevenage

Scientific Leader - Extractables and Leachables (E&L)

Salary not available. View on company website.

GSK, Stevenage

  • Full time
  • Permanent
  • Onsite working

Posted 1 day ago, 5 Aug | Get your application in today.

Closing date: Closing date not specified

Job ref: 6515d006087444fbbc803067a6705b3d

Location ref: Stevenage

Full Job Description

  • Project management and contribution to regulatory submissions
  • Extensively risk assess the relevant GSK portfolio to ensure patient safety from potential extractables and leachables.
  • Contribute to internal and external consortia to align with regulatory guidance and internal strategy on E&L
  • Provide support/training to more junior members of the team, particularly with respect to the risk assessment process and laboratory-based experimentation
  • Be active in supporting the development of methodology to detect E&L (Extractables and leachable) compounds using LC-MS (liquid chromatography-mass spectrometry) or (gas chromatography-mass spectrometry) GC-MS

    Bachelor of Science or PhD in Chemistry or related field
  • Experience in risk assessment and risk mitigation with regards to extractables and leachables essential.
  • Experience managing structured communications strategically to ensure alignment on project requirements and timelines.
  • Experience in independently handling high-quality data and reports
  • Experience in analytical chemistry, predominantly in the analysis of trace levels of compounds.
  • Experience in liaising with CMO's and CRO's
    • Work Arrangements: This role offers hybrid working (3 days per week minimum onsite). Working mode across the Stevenage and Ware R&D sites., Analytical Chemistry, Analytical Instrumentation, Analytical Laboratory, Analytical Thinking, Automation Technology, Bioprocessing, Chemical Processes, Data Analysis Tools, Dosage Forms, Drug Development, Matrix Leadership, Method Development, Technical Problem-Solving

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. An exciting opportunity for an expert in the field of Extractables and Leachables (E&L) to join a trace analysis team in an industry leading pharmaceutical company. The successful candidate will join a team that utilises state-of-the-art LC-MS and GC-MS instrumentation to provide key information for projects at all stages of pharmaceutical development. In this position, the successful candidate will primarily undertake risk assessment and mitigation of extractable and leachables in pharmaceutical manufacturing processes as well as leading collaboration across the GSK network, on behalf of R&D, to align on E&L control strategy. The successful candidate will work with a high level of autonomy to lead E&L analytical projects and develop capability within the laboratory environment as well as contributing to regulatory submissions and overseeing completion of work packages placed at CROs., Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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 at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov

Direct job link

https://www.jobs24.co.uk/job/scientific-leader-extractables-leachables-e-l-127150187
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