GCP Bioanalysis Senior Principal Scientist

Job Description Summary

Onsite - Cambridge, MA

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 this vital leadership role, you will use your leadership skills, scientific acumen, operational excellence, and regulated bioanalysis experience to lead a team of scientists in method development, validation and sample analysis focusing on our novel modality biologics portfolio.

 

Job Description

 

In setting the standard for efficient operations in a regulated bioanalytical lab: 

 

 Your key responsibilities will include: 

•  Responsible for overseeing the development/validation/sample analysis for mass spectrometry assays for pharmacokinetic and immunogenicity bioanalysis for all therapeutic modalities (proteins, mono, bi and tri-specific molecules, gene therapy, cell therapy, radioligand therapeutics and more).  

• Managing clinical study timelines and ensuring accuracy of project progress through company tracking tools. 

• Contributing to the strategic and operational aspects of the team and proposing/implementing modifications and improvements, both operationally and technologically, with a focus on continuous quality and efficiency improvements. 

• Contributing and reviewing relevant bioanalytical sections to regulatory and submission documents (e.g. IB, CTD, ISI). 

• Contributing to various advisory councils and stakeholder meetings representing the Bioanalytical group to facilitate your team’s contributions.  

• Hire and lead a team of up to 5 scientists carrying out bioanalytical development/validation and regulated sample analysis.   

  

Minimum Requirements: 

•  M.S. with 10+ years GCP experience in a pharmaceutical, CRO or related industry.  

• Demonstrated success building, leading and developing a scientific team. 

• Hands-on experience with the development of mass spectrometry assays with the proven ability to develop BA strategies across a variety of modalities using different technologies, including biologics. Preference given to candidates who have additional experience in working on protein and RNA therapeutics.  

• Strong engagement, interpersonal communication skills and ability to work in a dynamic matrix environment with frequently shifting priorities and timelines. 

• A thorough understanding of industry landscape and Health Authority guidelines. 

• Experienced in writing and supporting others contributing to the bioanalytical sections of regulatory and submission documents. 

Preferred Qualifications: 

• PhD

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: ht