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.

Director, Bioanalytical Outsourcing Expert 

The Bioanalytical Outsourcing Expert will be 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 prepare responses to regulatory agencies. 

 YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Bioanalytical Outsourcing Expert are to:

• 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;
• Developing of the bioanalytical strategy for new drug candidates;
• Monitoring of CRO’s operations in conjunction with the Bayer Quality Assurance (QA) group as well as regulatory and biosample management;
• Close cooperation with internal bioanalytic laboratories;
• Regular communication with CROs and face-2-face visits;
• Implement best practices for interaction with CROs by applying alliance management methodologies;
• Responsible for gathering and yearly review of key performance indicators (KPIs);
• Alignment with Toxicology outsourcing group for external toxicokinetics bioanalysis;
• Coordinating external CRO/Study Monitors.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Masters of Science Degree;
• Strong scientific knowhow in the area of SMOL bioanalysis using Liquid Chromatography-Mass Spectrometry techniques;
• 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.

Preferred Qualifications:

• PhD or equivalent in analytical chemistry, pharmacy or natural sciences;
• 8+ years relevant pharmaceutical industry experience in the area of bioanalysis; 
• Expertise in the area of biologics, peptides, cell and gene therapy (or other modalities); 
• Toxicokinetics evaluation experience. 

Employees can expect to be paid a salary between $163,182.40 and 244,773.60.  Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 07/07/25.