Principal Scientist- Bioanalytical laboratory- Discovery

Role & responsibilities

• Serve as the primary subject matter expert for all bioanalytical methods, including method development, validation, and sample analysis.
• Design and execute complex experiments for the quantification of drug candidates, metabolites, and biomarkers in biological matrices using a variety of platforms (e.g., Ligand Binding Assays, cell-based functional assays).
• Lead the evaluation, implementation, and troubleshooting of new analytical platforms and technologies to advance the laboratory's capabilities.
• Develop and influence bioanalytical strategies for multiple projects across the drug development pipeline.
• Manage project timelines and resources, serving as the bioanalytical representative for cross-functional project teams.
• Interact with internal and external partners, including Contract Research Organizations (CROs), to ensure project and scientific needs are met.
• Ensure all bioanalytical work is in compliance with relevant regulatory standards, including GLP, GCP, and ICH guidelines.
• Author, review, and approve critical regulatory documents, protocols, validation reports, and standard operating procedures (SOPs).
• Function as a key technical resource during regulatory inspections and client audits.
• Supervise, train, and mentor junior and senior scientists, fostering an environment of scientific excellence and professional development.
• Prioritize and schedule the workload of direct reports to meet project deadlines.
• Provide regular performance feedback and conduct annual reviews for team members.
• Present data, project updates, and scientific strategy to project teams, senior management, and clients.
• Contribute to scientific publications, presentations at conferences, and patent applications.

• Experience:

• Extensive, hands-on experience in bioanalytical method development, validation, and sample analysis within a regulated environment (GLP, GCP).
• Proven expertise with analytical techniques, including LC-MS/MS and Ligand Binding Assays (e.g., ELISA, MSD, Luminex).
• Experience with a variety of matrices such as plasma, serum, urine, and tissues.
• Demonstrated experience in leading projects, managing scientific staff, and fostering a collaborative team environment.

• Skills and Competencies:

• Exceptional problem-solving, troubleshooting, and analytical skills.
• Strong strategic and critical thinking abilities.
• Excellent written and verbal communication, and presentation skills.
• Proficiency with relevant software for data acquisition and analysis (e.g., Analyst, Softmax, LIMS).
• Deep knowledge of regulatory guidelines and industry best practices.
• Effective leadership and mentoring capabilities.