ADME Specialist
2 months ago
Slough, Slough, United Kingdom
Lifelancer
Full time
About the RoleWe are seeking a highly skilled Biotransformation Development Lead to join our global team and contribute to the development and drug discovery projects in immunology and neuroscience therapeutic areas.
Key Responsibilities- Plan, perform, and interpret metabolite profiling studies, including human ADME studies for regulatory submissions, in collaboration with the DMPK and Safety/Tox Representatives.
- Coordinate outsourced metabolite profiling studies with Contract Research Organisations.
- Provide guidance on regulatory requirements and apply biotransformation strategies.
- Generate, report, and communicate metabolic profiles in different biological matrixes from in vitro and/or in vivo studies, including active and reactive metabolites by interpretation of mass spectral data.
- Contribute to multi-parameter drug design, providing strong ADME input.
- Act with a high degree of autonomy, providing mentoring support to the biotransformation team and the wider DMPK department.
- Represent BT at relevant departmental, managerial, and project meetings.
- Stay up-to-date with current trends in biotransformation in development.
- Provide expert biotransformation knowledge linked to enzymology and DMPK properties to projects at all stages of the value chain, including life cycle management.
- Champion and develop new scientific approaches, technologies, and strategies.
- PhD. (or equivalent) in Biotransformation or DMPK related areas with analytical chemistry experience.
- Extensive experience in biotransformation and metabolism in the pharmaceutical industry, with a particular focus on supporting preclinical and clinical leads.
- Strong knowledge of international regulatory principles and guidelines regarding human metabolites, with particular emphasis on MIST.
- Experience in working with radiolabeled drugs and drug candidates.
- Strong background in metabolite identification experience in LC/MS, bioanalytical chemistry, and enzymology.
- Additional skills include having a drug hunter mentality, with expert knowledge in metabolic chemistry and the ability to link in-depth knowledge of drug metabolism, physicochemical properties into structural motifs to guide design of NCEs, working closely with medicinal chemistry.
- Experience with in-silico tools, AI data analysis and processing, and drug design platforms.
- Good understanding of the expression/functionality of the enzymes in various in vitro systems and the ability to apply understanding of drug metabolizing enzymes to elucidate biotransformation pathways and identify metabolites based on experimental data and in silico approaches.
- Able to work independently in analyzing, interpreting data, writing reports, and managing study flows.
- Awareness of literature and scientific advances in the field of drug metabolism and disposition.
- Strong communication and collaborative skills, with an ability to facilitate agile decision making in a team working environment.