Senior Scientist/Principal Scientist
BioPhase - San Diego, CA
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In this role, you will:Lead Metabolite Profiling: Oversee the identification and characterization of metabolites and conduct enzymology studies.Drive Innovation: Provide scientific and strategic input to guide medicinal chemists in optimizing chemical series and solving complex problems.Collaborate Cross-Functionally: Work closely with team members to ensure innovative solutions and successful project outcomes.Design and Manage Studies: Plan and execute in vitro soft-spot and tox species selection MetID studies and definitive in vivo MetID studies.Execute Experimental Work: Perform laboratory experiments and manage biotransformation studies conducted at CROs.Analyze and Present Data: Interpret mass spectra, prepare data summaries, and present findings to project teams and management.Contribute to Regulatory Documentation: Author and support regulatory reports and documents to facilitate clinical development.Requirements:Education & Experience: PhD in Organic Chemistry, Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline with 7+ years of industry experience; alternatively, MS/BS with 12+ years of relevant experience.Expertise: Extensive knowledge in drug metabolism, in vitro enzyme kinetics, ADME assays, and LC/MS bioanalytical methodologies.Biotransformation Studies: Proven experience in designing, executing, and reviewing biotransformation studies.Regulatory Knowledge: Understanding regulatory guidance related to biotransformation, including MIST, with experience in preparing biotransformation documents for regulatory submissions is considered a plus.Core Competencies:Communication Skills: Exceptional written and verbal technical communication abilities.Leadership & Influence: Proven ability to lead, guide, and influence teams in decision-making processes.Collaboration: Strong collaborative skills with the ability to build and maintain relationships across internal scientific functions and the broader scientific community.Autonomy & Teamwork: Capability to work independently and collaboratively within a multidisciplinary team setting.Data-Driven Analysis: Passion for data-driven analysis with a solid understanding of business-of-science thinking.Adaptability: Ability to excel in a fast-paced, highly matrixed environment.Technical Expertise: Deep knowledge of DMPK, biotransformation, enzymology, and DDI prediction strategies.Track Record: Demonstrated success in leading studies that support IND filings and contribute to drug discovery.CRO Management: Proficiency in managing CROs and a strong grasp of relevant regulatory guidance.The ideal candidate will have strong expertise in mass spectrometry, experience with regulatory submissions, and a proven track record of working effectively in a team environment.If you are a highly motivated individual with a passion for DMPK and drug development, apply today to join our innovative team!
Created: 2024-07-07