Principal Research Scientist I/II

Job Description

We are looking for a highly motivated person who can drive the development of antibody-drug conjugate drug substances, from FIH programs to late-stage development. The candidate will lead a group of scientists in the development of conjugation chemistry as well as downstream unit operations culminating in drug substance and may have supervisory responsibilities. The candidate will serve as the chemistry representative on the CMC team for ADC development programs and as such would be responsible for developing timelines and executing activities required for drug substance. The candidate must be able to mentor and develop staff with novel experimental approaches to answer difficult scientific questions. Working with analytical and manufacturing colleagues, the candidate will develop productive collaborations and communications with scientific teams.

Responsibilities:

The candidate will lead activities associated with process development and characterization for new ADC drug substances.

Lead the design and execution of process development and control strategies.

Lead process chemistry development for FIH programs.

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.

Collaborate to ensure successful CMC interactions with regulatory authorities.

The position involves multi-disciplinary interactions with other chemists, analytical chemists, engineers, drug product development, and program management. The selected candidate will collaborate with Asset Development Teams to advance clinical candidates. It is expected that the candidate will utilize his/her expertise across CMC disciplines to further program goals via collaborations with drug product development, regulatory affairs, and commercial operations.

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.