Advisor, Biotransformation - Novel Modalities

Responsibilities

• Bring deep technical expertise in oligonucleotide, siRNA, and other novel-modality biotransformation to build and strengthen a team of biotransformation scientists supporting Discovery and Development projects.
• Personally design, implement, and interpret biotransformation and bioanalytical studies for oligonucleotide, siRNA, and other novel-modality programs, remaining directly engaged in data generation and experimental work.
• Lead biotransformation tasks in designing and delivering biotransformation studies both internally and externally at CROs.
• Ensure high-quality data is generated by both internal and external sources.
• Understand, influence and apply regulatory guidance relevant to biotransformation/metabolism studies.
• Develop and implement strategic plans for biotransformation project support.
• Communicate the interpretation and impact of biotransformation results across ADME/Tox, project teams, and management effectively.
• Collaborate in a fast-paced work environment with internal staff and external CROs.
• Mentor junior staff.
• Engage in the external scientific community.

Qualifications

• PhD in analytical chemistry, or related field with 5-7+ years of hands-on work experience in biotransformation and drug metabolism, specifically in the field of oligonucleotides, siRNA, and other new modalities, including bioanalytical and metabolite-identification techniques (e.g., LC-MS/MS, hybridization-based assays).
• Additional Skills/Preferences:
• Demonstrated experience supporting biotransformation and/or bioanalysis of new modalities (i.e. ADCs, peptides, RNA, siRNA, ARCs).
• Deep understanding of biotransformation, and drug metabolism impact on moving compounds from Discovery through IND to NDA.
• Experience with regulatory guidance(s) for drug development.
• Experience with specific MS analysis software for new modalities (e.g. BioPharm Finder, MassMetaSite).