Beschreibung
Bioanalytical Manager in Small Molecule Bioanalytics - Reopening (m/f/d)
Reference: -en
Start: asap
Duration: 24 MM++
Main tasks:
- 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
Main qualifications
- PhD degree or equivalent with strong background in analytical chemistry of small molecules
- Profound working 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
Main advantages:
- You will work in an international environment
- Varied tasks in a renowned company
- Pleasant working atmosphere
- Central location
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Selina Denise Schweizer
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