Bioanalytical Manager in Small Molecule Bioanalytics
Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of manufacturing and selling of several drugs with treatment of Cancer.
We are currently looking for an enthusiastic Bioanalytical Manager in Small Molecule Bioanalytics to be based in Basel. If you have 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 in pharma environement, this is the right opportunity for you.
As a Bioanalytical Manager in Small Molecule Bioanalytics you will 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. You will interact with external CROs and internal project teams for conducting bioanalytical work according to regulatory guidance. You will manage full bioanalytical support for assigned multiple projects by providing support to internal project teams and directing bioanalytical work at CROs.
- 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.
Qualifications and Experience:
- 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);
- Relevant working/residency permit or Swiss/EU-Citizenship required.