Job Summary

The Bioanalytical Program Lead, supporting an Integrated Bioanalysis (IBA) General 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.

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 (dd

📌 Bioanalytical Program Lead (España)
🏢 LabConnect
📍 España