We are looking for a motivated Senior Scientist (m/f/d) Bioanalytics with a strong background in large-molecule bioanalysis, including ligand-binding, immunogenicity and MS-based approaches, in support of preclinical development activities for new and existing biologics in animal health.
In this position you will support our Preclinical Development team in Schwabenheim on a full-time, fixed-term basis for 2 years.
This position bridges early-stage research and regulated development by providing robust bioanalytical data and scientific interpretation to support pharmacokinetic, immunogenicity, biomarker, exposure-response and safety assessments, thereby enabling submissions to veterinary authorities such as FDA CVM and EMA/CVMP.
In this exciting role you will:
- Develop and implement bioanalytical strategies aligned with project milestones and regulatory expectations.
- Provide scientific leadership, regulatory expertise, and subject matter expertise in large-molecule bioanalysis within cross-functional teams
- Identify and mitigate risks related to assay performance, comparability, assay transfer to CROs, and study execution.
- Prepare bioanalytical contributions to regulatory submissions and scientific presentations for internal stakeholders and veterinary authorities such as FDA CVM and EMA/CVMP.
- Maintain and expand collaborations with contract research organizations and provide effective oversight to ensure quality, compliance and timely delivery.
- Represent Preclinical Bioanalytics in international, multidisciplinary project teams.
Education / Experience
- Ph.D. in Biochemistry, Biology, Chemistry, Immunology, Pharmacology, or related discipline (or equivalent advanced education)
Experience
- Significant experience in regulated bioanalytics (GLP/GxP environment)
- Strong expertise in large-molecule bioanalysis, including PK/PD assays, immunogenicity assessment
- Proven experience in assay development, validation, and troubleshooting
- Experience with CRO management and external collaborations
- Familiarity with regulatory expectations for preclinical development
Core Competencies
- Strategic thinking and scientific leadership
- Deep regulatory and compliance knowledge
- Strong communication and stakeholder management skills
- Ability to lead cross-functional and global teams
- Problem-solving and risk management
Contract Details
- Duration: Temporary (2 years)
- Location: Schwabenheim
- Full-time, hybrid
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
People with severe disabilities and their equals are given preference if they are equally qualified.
Required Skills:
Analytical Chemistry, Analytical Chemistry, Assay Development, Biopharmaceutics, Clinical Data Interpretation, Cross-Functional Teamwork, Detail-Oriented, Experimentation, Genetic Toxicology, High Resolution Mass Spectrometry (HRMS), Immunoassays, Immunochemistry, Immunogenicity Assays, Immunology, Immunotherapy, Laboratory Techniques, Personal Initiative, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacotherapeutics, Pharmacotherapy, Reviewing Literature, Statistical Analysis, Taking Initiative {+ 2 more}
Preferred Skills:
