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Bioanalytical Outsourcing Scientist 

Position purpose:

Being responsible for the placement, monitoring and scientific review of bioanalytical studies and method development/ validation at Contract Research Organizations (CROs) as well as the assurance of the quality with respect to requirements by the regulatory agencies. Preparation of documents for INDs and NDAs as well as preparing responses to regulator agencies.

Key tasks:

• Selection of external providers for bioanalysis
• Proper planning with regard to timelines for all small molecule (SMOL) bioanalytical studies to be outsourced

• Continuously monitoring the performance of the CRO by in depth review of critical tasks; Make sure to provide quality data and reports on time
• Establishment of bioanalytical methodology at CRO including method transfer/ development/ (cross)-validation in support of the Bayer bioanalytical department
• Developing of the bioanalytical strategy for new drug candidates
• Monitoring of CRO’s operations in conjunction with the Bayer Quality Assurance (QA) group
• Regular communication with CROs and face-2-face visits (if the pandemic situation allows)
• Implement best practices for interaction with CROs by applying alliance management methodologies
• Close cooperation with QA, regulatory, biosample management
• Responsible for gathering and yearly review of key performance indicators (KPIs)
• Alignment with Toxicology outsourcing group for external toxicokinetics bioanalysis

Qualifications & Competencies:

• University degree in pharmacy or natural sciences (m/f/d), preferably Ph.D., or equivalent and extensive professional
• >8 years relevant pharmaceutical industry experience in the area of bioanalysis
• Strong scientific knowhow in the area of SMOL bioanalysis
• Additional expertise in the area of biologics, peptides, cell and gene therapy (or other modalities) is a plus
• Experience in working in international and multidisciplinary teams
• Proven experience in working relationships with external partners and in collaborations
• Strong organizational skills
• Several years of professional experience within a regulated environment (GLP)
• Broad understanding of global drug discovery and development
• Excellent networker and team player with proven networking skills
• Strong proficiency in English

Location:

Spain : Cataluña : Barcelona  

Division:

Pharmaceuticals 

Reference Code:

858033