Massachusetts Jobs

Job ID REQ-10018459 Onsite - Cambridge, MA 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