Demo
Mainz, Germany | full time | Job ID: 8283
The Senior Director 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.
Your main responsibilities are:
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
What you have to offer:
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
Your Benefits:
It's our priority to support you:
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 8283 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
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55131 Mainz, RP
Full Time
55131 Mainz, RP
Full Time
55131 Mainz, RP
Full Time
55131 Mainz, RP
Full Time