Scientific Project Lead Analytical Excellence (all genders)
Mainz, Germany | full time | Job ID: 8283
The Scientific Project Lead Analytical Excellence will ensure scientific excellence in analytical method development by establishing systematic approaches and state-of-art tools. This covers the definition of phase-appropriate requirements on method development, establishment of state-of the art tools to ensure method fit for purpose - characterization or QC routine testing. Being accountable for the analytical excellence within analytical development, the Senior Director will guide teams to perform successful analytical method development, root-cause investigations, and troubleshooting activities.
To ensure that analytical method target profiles are set-up fit for intended purpose and method development is phase appropriate
To propose, develop, and establish tools for method development and robustness studies which can be applied for different technologies and leverage from prior knowledge of the analytical platform
To guide teams by development and troubleshooting of analytical methods by applying state-of-art tools and systematic approaches
To support teams on hand-over of analytical methods to other functions (QC) and other sites
To identify critical issues related to method performance and robustness and proactively implement activities for their resolution
Representation of the analytical development organization in governance and review meetings to share guidance or as analytical SME
Development of internal guidelines to ensure harmonized analytical method development across programs and technologies and enabling analytical teams by training
An advanced degree in natural sciences (pharmacy, chemistry, biotechnology, biology or equivalent)
Profound professional experience in the analytical development of pharmaceuticals covering different modalities and throughout preclinical and clinical stages
Proven knowledge in analytical method development, validation, and related robust studies applied during pharmaceutical product lifecycle
Strong team leadership experience, typically gained through at least 10 years of experience with line management responsibilities and in matrix organizations
Broad knowledge of analytical methods and technologies for biologics. Experiences with different modalities as DNA, RNA, peptides and antibodies are a plus
Solid know-how of regulatory requirements for pharmaceutical development
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare