Bioanalytical Study Director

Introduction to Role :

Are you ready to make a significant impact in the world of bioanalysis? As part of the Integrated Bioanalysis (IBA) Global Team, you will be leading the design and implementation of robust bioanalytical strategies. This role is pivotal in ensuring lab-based activities are aligned with the context of use. You will be working in a matrix environment, managing aspects such as experimental design and tech transfer. This role requires close interaction with other scientific and technical staff in the lab. If you have a strong track record in regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas, this could be the perfect opportunity for you!

Accountabilities :

You will interact closely with scientists who are primarily lab based, and you will be required to aid in experimental design where required. This is a highly visible role, and you will be required to use your scientific knowledge and expertise while working with a range of collaborators and cross functional groups. You will also 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.

Essential Skills / Experience :

• 10+ yrs experience in Bioanalysis required
• Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK / CK, PD and immunogenicity assessments (humoral and cellular)
• Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.
• Deep understanding of small molecule and peptide Bioanalysis by LCMS
• Experienced in regulated bioanalysis for multiple drug modalities.
• Proven publication and presentation record
• Exceptional verbal and written communication skills

Desirable Skills / Experience :