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Director Analytical Development (m/f/d)
Laupheim
Aktualität: 24.11.2022

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24.11.2022, Rentschler Biopharma SE
Laupheim
Director Analytical Development (m/f/d)
As Director Analytical Development (m/f/d) you will be responsible for different teams and laboratory units reporting to the Quality Control department. You will lead and support analytical activities and strategies related to method development, -validation and comparability assessments for multiple early- and late-stage programs for our customers. Lead and mentor internal and external teams throughout the analytical lifecycle (method development and validation) of drug substance, drug product and intermediates Define and oversee science-driven, phase-appropriate analytical development and validation strategies and related business processes for internal and external labs that are consistent with cGMP and international guidelines Work with multidisciplinary teams and collaborate with other areas in process development, manufacturing, as well as external parties Deliver analytical solutions that enable process -, product - and analytical control strategy development Support the definition of critical quality attributes and establish robust analytical control strategies that can be transferred into Quality Control and successfully registered globally Develop and manage method development and validation metrics for performance improvement of the team Represent Analytical Development and Quality Control to internal and external customers Provide leadership to aid in analytical investigations and assay trouble shooting Review and approve analytical documents including but not limited to protocols, reports and procedures Review analytical sections in regulatory submission documents (e.g. IND, IMPD, MAA, BLA) Identify and monitor disruptive analytical technologies and regulatory trends
Scientific degree in life sciences with a focus on analytical techniques for proteins and more than 5 years of experience in analytical development in the biopharmaceutical industry Strong leadership skills and experience with the leadership of large organizational units You are a team player and enjoy working in multidisciplinary teams irrespective from hierarchic levels Strong background in method development, validation and regulatory guidelines for protein drug substances (CE, HPLC, ELISA, Bioassay) Sound understanding of protein chemistry and associated CQAs Experience in the management of organizations working on a variety of products is a plus

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