Job Description

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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

YOUR APPLICATION

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location:

Spain : Cataluña : Barcelona

Division:

Pharmaceuticals

Reference Code:

858033