Principal Research Scientist II, Process Chemistry (Radiochemistry)

Responsibilities

• Lead activities associated with labeling and characterization for new drug substances.
• Lead the design and execution of labeling strategies.
• Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management.
• Mentor staff in troubleshooting strategic and experimental issues.
• Author and review key regulatory documents, laboratory data, technical memos, standard operating procedures, and reports.
• Collaborate to ensure successful CMC interactions with regulatory authorities.
• Utilize expertise across disciplines to advance the pipeline.
• Encourage ideas for continuous improvement activities and initiatives within the Radiochemistry team.
• Understand, adhere, and ensure compliance with corporate standards regarding code of conduct, safety, radiosafety and GXP compliance.

Qualifications

• BS (16+ years); MS (14+ years) or PhD (8+ years) in Chemistry or allied field, with 8+ years of previous work experience in a pharmaceutical laboratory setting.
• Experience in radiolabeling and safety.
• Experience in managing and developing scientific leaders is required.
• A strong understanding of synthetic organic chemistry, process development, GXP compliant processes, and radiolabeling strategies to appropriately label compounds to meet the study needs.