{"id":1323308,"url":"https://alion.io/job/catalym-senior-scientist-bioanalytics-mfd","title":"(Senior) Scientist Bioanalytics (m/f/d)","company":{"id":3781716,"name":"Catalym","domain":"catalym.com","url":"https://alion.io/company/catalym","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Personio","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"unspecified","remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":87000,"max_usd":175000,"period":"year","method":"global_role_seniority_cell","sample_n":1403},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-03T09:32:46Z","employer_posted_date":"2026-09-03","last_verified_at":"2026-10-22T17:23:28Z","board_verified":true,"closed_at":null,"days_open":49,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":49},"description":"Your mission\nWe are seeking a highly motivated and scientifically driven (Senior) Scientist Bioanalytics to join our Bioanalytics team. You will contribute to the planning, execution and oversight of bioanalytical activities supporting clinical and non-clinical development programs.This role involves close collaboration with Translational Research and Clinical Biomarkers, Clinical Pharmacology, Non-Clinical Safety, Clinical Operations, Clinical Development, Regulatory Affairs, and external laboratories. You will provide scientific and operational oversight of pharmacokinetic (PK), immunogenicity (ADA/NAb) and pharmacodynamic (PD) assays supporting drug development through non-clinical and clinical programs.\nKey Responsibilities:\nBioanalytical Strategy & Program Support\nContribute to the development and execution of bioanalytical strategies within non-clinical and clinical development programs.\nIndependently lead bioanalytical activities and proactively address scientific and operational challenges in a cross-functional environment.\nSupport the selection, development, qualification/validation and implementation of PK, immunogenicity (ADA/NAb),andPD assays.\nProvide scientific input to relevant clinical and non-clinical development documentation.\nEnsure bioanalytical activities are aligned with overall program objectives, scientific best practices, and applicable regulatory expectations.\nSupport bioanalytical assay strategy discussions for non-clinical and clinical studies.\nEnsure bioanalytical activities are conducted in accordance with applicable GxPrequirements and regulatory guidance.\nCRO and External Laboratory OversightServe as the primary scientific contact for external bioanalytical laboratories and service providers.\nSupport external vendor selection, qualification, and governance activities.\nMonitor laboratory performance, data quality, and timelines, and support issue resolution.\nManage outsourced assay development, validation, and clinical and non-clinical sample analysis activities.\nReview and approve method validation reports, clinical and non-clinical sample analysis plans and reports, data transfer specifications, and other study-related documentation.\nData Review and InterpretationEvaluate bioanalytical results and provide scientific recommendations to support program decision-making.\nSupport the integrated interpretation of PK, ADA, NAb, and PD data.\nContribute to internal decision-making, cross-functional discussions, study reports, regulatory documentation, and scientific publications.\nCross-Functional CollaborationAct as a scientific interface between internal stakeholders, external consultants, and bioanalytical service providers, ensuring alignment on assay strategy, study execution, and interpretation of bioanalytical data.\nWork closely with Translational Research and Clinical Biomarkers, Clinical Pharmacology, Non-Clinical Safety, Clinical Operations, Clinical Development, Regulatory Affairs, and external subject matter experts and consultants supporting CatalYm'sdevelopment programs.\nPresent bioanalytical strategies, results, and recommendations to project teams and management.\nYour profile\nPh.D., M.Sc., or equivalent degree in Immunology, Biochemistry, Pharmacology, Pharmaceutical Sciences, Life Sciences, or a related discipline.\n2-5 years of industry experience in bioanalysis within the biotechnology, pharmaceutical, or CRO environment, including experience supporting bioanalytical programs and working with external laboratories and service providers.\nExperience with PK, ADA, NAb, and PD assay development, validation, and sample analysis in non-clinical and/or clinical studies.\nKnowledge of applicable FDA, EMA, and ICH bioanalytical and immunogenicity guidelines.\nExperience managing external laboratories and outsourced studies.\nKnowledge of biologics, immunology, oncologyand immuno-oncology is preferred.\nWhy us?\n We offer:The opportunity to contribute to the clinical development of a promising, innovative cancer therapy.\nAn operational role at the interface of translational research, clinical biomarkers, clinical operations, and clinical bioanalytics.\nA collaborative and purpose-driven team environment.\nFlexible working arrangements, including partial remote work while maintaining regular on-site collaboration.\nA secure, permanent employment contract with competitive compensation and attractive employee 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shot","p_open":0.4,"p_active":0.571,"p_room":0.45,"age_days":48,"expected_fill_days":29,"reasons":["seen:48","win:tail"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/catalym-senior-scientist-bioanalytics-mfd","json_url":"https://alion.io/job/catalym-senior-scientist-bioanalytics-mfd.json","meta":{"generated_at":"2026-10-22T18:42:09Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per 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