Bioanalytical Program Lead - UK in Cambridge

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.

• 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.

• 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.

• 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.

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.