Principal Research Scientist I Chemistry

Role Summary

Principal Research Scientist I/II to conduct process research and development of drug conjugates from pre-clinical through clinical development. Lead in the development of conjugation chemistry and downstream unit operations culminating in drug substance, with potential supervisory responsibilities. Serve as the chemistry representative on the CMC team for drug-conjugate development programs and develop timelines and execute activities required for drug substance. Mentor staff and collaborate with analytical and manufacturing colleagues to advance programs.

Responsibilities

• The candidate will lead activities associated with process development and characterization for new drug conjugates.
• Develop and characterize drug-conjugate (and other modalities) processes in the laboratory and translate them to scalable processes.
• 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 and reports.
• The position involves multi-disciplinary interactions with organic chemists, analytical chemists, engineers, drug product development, and program management. The selected candidate will collaborate with cross-functional CMC teams to advance pre-clinical and clinical candidates.
• The candidate will encourage ideas for continuous improvement activities and initiatives within work group.
• The candidate will understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance.

Qualifications

• BS (14+ years); MS (12+ years) or PhD (6+ years) in Chemistry or allied field, with 4+ years of previous work experience in a pharmaceutical laboratory setting.
• Experience in drug-conjugate process development.
• Proven scientific leadership; strong interpersonal and communication skills for facilitating collaborations and a demonstrated ability to lead cross-functional process development teams.
• The successful candidate will have a strong understanding of modern organic chemistry, mechanistic theory, control strategy development, and regulatory starting material strategies.
• An understanding of global regulatory expectations and experience with authoring development reports and regulatory filings is highly desirable.

Skills

• Leadership and collaboration across diverse teams; ability to mentor staff and troubleshoot strategic and experimental issues.
• Strong foundation in organic chemistry, mechanistic theory, and regulatory materials strategies.
• Effective communication with internal and external stakeholders and track record of contributing to cross-functional teams.