An excellent opportunity has arisen to join a leading pharmaceutical company as a Bioanalytical Manager in Small Molecule Bioanalytics.
Bioanalytical Manager in Small Molecule Bioanalytics
Act as Bioanalytical Expert in a regulated bioanalysis environment to deliver high quality and timely bioanalytical strategies, data and reports to non-clinical and clinical project teams. Interact with external CROs and internal project teams for conducting bioanalytical work according to regulatory guidance. Manage full bioanalytical support for assigned multiple projects by providing support to internal project teams and directing bioanalytical work at CROs. This role reports to the Head of Small Molecules Regulatory Bioanalysis.
Ensure the development/transfer and validation of specific and sensitive bioanalytical methods required for the drug candidates and any concomitant/ interaction therapies in a given project working closely with the internal labs and external providers (CROs)
Manage and direct analysis of samples and timelines from non-clinical and clinical studies for the project at CRO labs
Participate actively in DMPK, clinical and study management sub-teams
Review protocols and guide project teams in all aspects of bioanalytical work required for the project
Review data and reports for regulatory submissions. Support filings and answer any questions coming from the regulatory agencies, as applicable
Ensure full compliance with the current global and local bioanalytical regulatory guidance
Ensure that the most advanced and most efficient procedures are used at the CRO
Remain current and continually develop expertise in bioanalytical sciences of small molecules, including oligonucleotides analysis
PhD degree or equivalent with strong background in analytical chemistry of small molecules and at least 5 years' experience in a Bioanalytical or DMPK department, preferably of a Pharma company
Demonstrated experience in the area of bioanalytics of small molecule drugs including oligonucleotide analysis and CRO monitoring
Sound knowledge of the GxP, specific to bioanalytical work
Recent and relevant work in Pharma company lab or outsourcing function where regulated bioanalysis is run according to the FDA and EMA guideline
Commitment to maintain high quality of delivered data, compliance and scientific quality Excellent communication skills and ability to work in a matrix organization
Ability to represent function and provide leadership in a multidisciplinary project team Self-motivation, ability to work independently in a matrix organization, team player, attention to details, ability to focus and prioritize, excellent communication skills
Excellent knowledge of English (spoken and written)
Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.
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