Job Summary The Bioanalytical Program Lead, supporting an Integrated Bioanalysis (IBA) Global Team, will lead the design and implementation of robust bioanalytical strategies. This role will ensure lab-based activities are aligned with context of use, working closely with other scientific and technical lab staff in a matrix environment to manage aspects such as experimental design and tech transfer in regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas. Please note: this role is best suited for candidates within proximity to Cambridge. Essential Duties and Responsibilities Responsible for interacting closely with scientists who are primarily lab-based, aiding in experimental design where required. Serve as the bioanalytical lead on the client’s projects, using strategic thinking, scientific knowledge and expertise while working with a range of collaborators and cross-functional groups. Act as a Subject Matter Expert in regulated bioanalysis across a range of modalities. Contribute to and author regulatory documents to support submissions across a range of countries and geographies. Work with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents, and respond to Health Authority questions. Education and Experience Bachelor of Science in relevant subject required. At least 10 years of experience in Bioanalysis required (large and small molecule). Proven experience required as a Subject Matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (cellular and humoral). Required experience as a bioanalytical lead across diverse project teams - defining, leading and executing on bioanalytical strategy to advance a portfolio that may include Biomarker and Target Engagement strategy for dose decision endpoints. Skills and Ability Required scientific ability to assess and discern the advantages and pitfalls of a range of analytical techniques which may include molecular assays (ddPCR, 1PCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry. Requires deep understanding of small and large molecule Bioanalysis. Requires proven publication and presentation record. Requires exceptional written and verbal communication skills. Requires proficiency in speaking and writing in the English language. Preferred knowledge of immunology and/or metabolic diseases. Preferred experience working in a matrix environment. Supervisory Responsibilities: None Physical Demands: While performing the duties of this job, the occupant is regularly required to: Prolonged periods of sitting at a desk and working on a computer. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Use hands and fingers to operate a computer and other office equipment.
