GCP Bioanalysis Principal Scientist - Novartis
Cambridge, MA
About the Job
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.
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.
Source : Novartis