GCP Bioanalysis Principal Scientist

Onsite
About the role:
As a Principal Scientist in the Translational Medicine Drug Disposition Bioanalytical group, you will have the opportunity to make a difference. In this key role, you will apply your bioanalytical expertise and leadership skills to design and conduct studies for our novel modality biologics portfolio. If you have a collaborative nature, a commitment to teamwork across an organization and a relentless focus on improving patient care we want you to apply.
Your Key Responsibilities:
Designing, developing, validating assays and performing clinical sample analysis using biological techniques for PK, PD and immunogenicity following SOPs and guidelines in a supervisory role
Participating in or leading the bioanalytical strategy sub-team discussions and overseeing the execution of the strategy.
Data processing, evaluating results, interpreting data, and drawing relevant conclusions. Critically analyzing data on study and project levels and communicating findings in a clear and timely manner.
Keeping timely raw data records in accordance with company and health authority guidelines, as an individual contributor and/or supervisor.
Managing study timelines and ensuring accuracy of project progress through company tracking tools.
Authoring study protocols, reports, and contributing to health authority documents.
Supervising, coaching and/or mentoring in a matrix team laboratory environment.