Senior Analytical Method Development Scientist
3 days ago
At Freeline Therapeutics, we're revolutionizing the treatment of serious and debilitating chronic diseases with our cutting-edge gene therapy platform. As a key member of our dedicated team, you'll play a pivotal role in advancing our science and developing innovative, one-time treatments that set new standards of care.
Key Responsibilities:- Manage analytical method transfer and assay validation at Contract Research Organizations (CROs) to ensure regulatory compliance and technical excellence.
- Partner with research teams to develop strategies for robust method development on analytical methodologies, with the goal of translating them to CROs for validation.
- Lead analytical sub-teams for project teams, providing leadership for significant tasks such as specification setting, stability, comparability, and more.
- Support the development of systems and processes for managing Quality Control (QC) release/stability and clinical data generated by third parties for our products, in support of product release and regulatory approval throughout their lifecycle.
- Bachelor's of Science or equivalent degree.
- Experience in a Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) laboratory in the Pharmaceutical/Biotechnology industry.
- Thorough understanding of method development and validation requirements, principles, and regulations.
- Good understanding of drug development and current trends in Analytical Sciences.
- Knowledge of documentation requirements in a GMP laboratory, including maintenance of data integrity.
- Experience writing methods, protocols, Standard Operating Procedures (SOPs), and reports.
- Experience writing IND/BLA sections related to analytical test methods and specifications.
- Early and late-stage clinical development experience.
- Significant experience and understanding of the requirements for Quality Control of Investigational Medicinal Products (IMPs), INDs, and more.
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Stevenage, Hertfordshire, United Kingdom Freeline Therapeutics Full timeUnlock the Potential of Gene TherapyAt Freeline Therapeutics, we're revolutionizing the treatment of serious and debilitating chronic diseases with our cutting-edge gene therapy platform. As a key member of our team, you'll play a crucial role in advancing our science and developing innovative, one-time treatments that set new standards of care.Key...
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Stevenage, Hertfordshire, United Kingdom Freeline Therapeutics Full timeUnlock the Potential of Gene TherapyAt Freeline Therapeutics, we're revolutionizing the treatment of serious and debilitating chronic diseases with our cutting-edge gene therapy platform. As a key member of our team, you'll play a crucial role in advancing our science and developing innovative, one-time treatments that set new standards of care.Key...
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Senior Scientist
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Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full timeJob Title: Senior ScientistWe are seeking a highly motivated and experienced Senior Scientist to join our High Throughput Characterisation (HTC) team in Large Molecule Discovery. The successful candidate will have a strong background in biophysics and protein analytics, with expertise in characterising protein-protein interactions using state-of-the-art SPR...
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Senior Scientist
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Senior Scientist
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Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full timeJob Title: Senior ScientistWe are seeking a highly motivated and experienced Senior Scientist to join our High Throughput Characterisation (HTC) team in Large Molecule Discovery. The successful candidate will have a strong background in biophysics and a proven track record of characterising protein-protein interactions using state-of-the-art SPR technologies...
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Senior Scientist
6 days ago
Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full timeJob Title: Senior ScientistWe are seeking a highly motivated and experienced Senior Scientist to join our High Throughput Characterisation (HTC) team in Large Molecule Discovery. The successful candidate will have a strong background in biophysics and a proven track record of characterising protein-protein interactions using state-of-the-art SPR technologies...
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Senior Analytical Development Manager
1 week ago
Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob SummaryWe are seeking a highly skilled and experienced Senior Analytical Development Manager to lead our analytical development team in the development, manufacturing, and release of drug substances and drug products. The successful candidate will have a strong background in analytical chemistry and pharmaceutical industry experience.Key...
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Stevenage, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeAbout the RoleWe are seeking a highly skilled Senior Scientist to join our Digital Analytical Platforms team within Analytical Development. As a key member of our team, you will play a critical role in accelerating scientific and R&D delivery through the development and implementation of innovative analytical chemistry platforms.Key...
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Senior Scientist
6 days ago
Stevenage, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeAbout the RoleWe are seeking a highly skilled Senior Scientist to join our Digital Analytical Platforms team within Analytical Development. As a key member of our team, you will play a critical role in accelerating scientific and R&D delivery through the development and implementation of innovative analytical chemistry platforms.Key...
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Analytical Scientist
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Analytical Scientist
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Senior Pharmacovigilance Scientist
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Senior Research Scientist
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionOverviewThe Associate Director of Analytical Development will lead a team of analytical scientists responsible for the development, manufacturing, release, and stability testing of drug substances and drug products. This role requires strong leadership and technical expertise in analytical development, with a focus on small molecule and...
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionOverviewThe Associate Director of Analytical Development will lead a team of analytical scientists responsible for the development, manufacturing, release, and stability testing of drug substances and drug products. This role requires strong leadership and technical expertise in analytical development, with a focus on small molecule and...