Salary not disclosed
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Role overview
Job description
- Ph.D. or M.Sc. degree in biochemistry, immunology, pharmacology, analytical sciences, molecular biology, biotechnology, or a related scientific discipline, with significant relevant industry experience in regulated bioanalysis supporting nonclinical studies and clinical trials.
- A minimum of approximately 12 years relevant industry experience, including progressive leadership responsibility and change management within ligand binding or large molecule bioanalysis.
- Deep scientific understanding and practical experience with ligand binding assay principles with strong experience with large molecule pharmacokinetic, biomarker and immunogenicity bioanalysis.
- Working knowledge of applicable regulatory expectations and industry guidance governing regulated bioanalysis, including relevant FDA, EMA, ICH, and GLP/GCP expectations.
- First-hand experience as a Study Director, Principal Investigator, Bioanalytical Project Manager or equivalent role supporting regulated studies within a GLP/GCP-compliant environment.
- Experience participating in or supporting sponsor audits and Health Authority regulatory inspections.
- Demonstrated experience managing, developing, and leading scientific teams, preferably within a growing or changing laboratory environment, with demonstrated ability to develop talent, manage performance, and foster collaboration and knowledge sharing.
- Demonstrated ability to translate business demand into staffing, equipment, technology, capacity, and financial plans.
- Strong client-facing skills with the ability to explain complex scientific and regulatory concepts clearly to both technical and non-technical audiences.
- Experience supporting proposals, scientific presentations, bid defenses, and business development activities.
- Knowledge of laboratory automation, data acquisition and analysis systems, electronic laboratory systems, and LIMS platforms such as Watson or equivalent systems.
- Experience utilizing scientific software, data analysis systems, statistical tools, and emerging digital technologies.
- Strong written and verbal communication skills and demonstrated ability to influence across functions and organizational levels.
- Demonstrated ability to manage multiple priorities, resolve complex scientific and operational problems, and make sound decisions in a fast-paced environment.
- A strong external scientific profile, including participation in professional organizations, scientific meetings, industry working groups, publications, or presentations, is preferred.
Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
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About this listing
- Source: Celerion's official careers site · still listed there on 12 Nov 2026
- Posted 26 Mar 2025
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What they are looking for
Skills & requirements
Qualification
Ph.D. or M.Sc. degree in biochemistry, immunology, pharmacology, analytical sciences, molecular biology, biotechnology, or a related scientific discipline, with significant relevant industry experience in regulated bioanalysis supporting nonclinical studies and clinical trials
Department · Bioanalytical Services
Hiring company
Celerion
Celerion is a leading clinical research organization providing early phase clinical research, bioanalytical services, and drug development expertise.
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