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Scientist Bioanalytics & Pharmacokinetics

Germany, Heidelberg · Job Posted June 29, 2026
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Job Description

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

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