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Critical Reagent Team Lead, PK Sciences (342121BR)





Cambridge, Massachusetts, United States

Job Description 1,040,000. That is the number of samples managed by the Global Bioanalytics team in 2021. Do you want to join a team recognized with a Novartis Institutes for BioMedical Research Team Award for their quality focus and responsiveness? Are you looking to build and grow your leadership opportunities? As a Senior Principal Scientist in the Translational Medicine Drug Disposition Bioanalytical group, you will have the opportunity to make a difference. 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.

In the Senior Principal Scientist role, you will spend approximately 40% of your time in the lab applying your hands-on expertise in ligand binding assays to the characterization of the critical reagents used on this platform. You will invest the remaining time to manage the day-to-day activities of an elite team of three scientists tasked with providing the LC-MS, biophysical characterization data and logistical support for these reagents for both internal labs and external CRO partners. Additionally, using your leadership skills, you will drive continuous process improvements for the end-to-end management of these assay critical reagents ensuring timely delivery of high quality data for both preclinical and clinical assay development. You will also bring new ideas and approaches to improve Novartis’ critical reagent strategy, on a program and overall pipeline scale.

In setting the standard for operational excellence with a focus on continuous quality improvement:

Your main responsibilities will include but are not limited to:

In the lab: [~2 days/week]:

• Developing and qualifying assays for ligand binding platforms for pharmacokinetic and immunogenicity bioanalysis for all therapeutic modalities (proteins, mono, bi and tri-specific molecules, gene therapy, cell therapy, Radioligand therapeutics and more).
• Qualifying reagents used in these assays with well-defined working practices to ensure assay reproducibility and robustness.
• Provide mentoring and training to lab staff on assay methodology and data analysis, as appropriate.

In the office: [~3 days/week]:

• Writing and reviewing method working practices to ensure compliance with internal and external best practices for reagent characterization.
• Monitoring and ensuring the team delivers high quality data within defined timelines.
• Reviewing the operational aspects of the team and proposing modifications and improvements, both operationally and technologically, with a focus on continuous quality improvement.
• As a member of the BA Labs leadership team, participate in various advisory councils and stakeholder meetings representing the critical reagent team and Bioanalytical group to facilitate your team’s contributions.