This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Location: Heidelberg, Germany (on site) Start Date: October 2026 Responsibilities: Support anti-idiotypic antibody generation at external CROs and characterization efforts Plan, conduct, evaluate, and qualify bioanalytical assays (focus on ligand binding assays) in-house, at the highest level of scientific integrity Arrange assay transfers to clinical CROs and validate methods according to regulatory standards for use in FIH studies Support in the design and interpretation of external non-clinical in vivo PK studies (GLP and non-GLP) for large molecule drug candidates (ADCs and TCEs) Apply PK and PBPK models using in vivo study data from different species, employing industry-standard software Prepare expert reports, scientific documents, and presentations in English Work collaboratively within project teams and communicate efficiently with multidisciplinary teams to design and prosecute studies in line with the strategic direction of the projects Requirements: Ph.D. in Life Sciences, Bioengineering, Pharmacology or related subject area with 3+ years of pharmaceutical development experience in pharma, biotech, or a CRO, with a focus on pharmacokinetics and bioanalytics. Experience with designing, optimizing, qualifying, and validating bioanalytical assays using ECL-based immunoassays (Meso Scale Discovery) and ELISA platforms to support PK/TK assessments, including solid understanding of respective regulatory guidelines. Strong laboratory skills, including the ability to independently execute the bioanalysis of primary samples, handling of biological fluids/matrices (biosafety level S1+ S2) and training of technical assistants in respective assays. Experience in maintaining laboratory notebooks and conducting data-fitting using commercially available software packages such as GraphPad Prism. Training in PK data analysis and interpretation and PK/PD modeling, using industry standard software packages e.g. Phoenix WinNonlin. Knowledge in R would be beneficial. Excellent verbal & written communication and presentation skills. Commitment to fostering a strong quality-driven culture. Fluency in English (spoken and written) is required. German skills are a plus. Experience in a quality-regulated environment is a benefit.
Job Responsibility
Support anti-idiotypic antibody generation at external CROs and characterization efforts
Plan, conduct, evaluate, and qualify bioanalytical assays (focus on ligand binding assays) in-house, at the highest level of scientific integrity
Arrange assay transfers to clinical CROs and validate methods according to regulatory standards for use in FIH studies
Support in the design and interpretation of external non-clinical in vivo PK studies (GLP and non-GLP) for large molecule drug candidates (ADCs and TCEs)
Apply PK and PBPK models using in vivo study data from different species, employing industry-standard software
Prepare expert reports, scientific documents, and presentations in English
Work collaboratively within project teams and communicate efficiently with multidisciplinary teams to design and prosecute studies in line with the strategic direction of the projects
Requirements
Ph.D. in Life Sciences, Bioengineering, Pharmacology or related subject area with 3+ years of pharmaceutical development experience in pharma, biotech, or a CRO, with a focus on pharmacokinetics and bioanalytics
Experience with designing, optimizing, qualifying, and validating bioanalytical assays using ECL-based immunoassays (Meso Scale Discovery) and ELISA platforms to support PK/TK assessments, including solid understanding of respective regulatory guidelines
Strong laboratory skills, including the ability to independently execute the bioanalysis of primary samples, handling of biological fluids/matrices (biosafety level S1+ S2) and training of technical assistants in respective assays
Experience in maintaining laboratory notebooks and conducting data-fitting using commercially available software packages such as GraphPad Prism
Training in PK data analysis and interpretation and PK/PD modeling, using industry standard software packages e.g. Phoenix WinNonlin
Excellent verbal & written communication and presentation skills
Commitment to fostering a strong quality-driven culture
Fluency in English (spoken and written) is required
Knowledge in R would be beneficial
German skills are a plus
Experience in a quality-regulated environment is a benefit
Nice to have
Knowledge in R would be beneficial
German skills are a plus
Experience in a quality-regulated environment is a benefit