Analytik NEWS
Online Laboratory Magazine
12/02/2022

Director Analytical Development (m/f/d)

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What is important to us:

  • 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

Tasks and responsibilities

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


» Job description


Employer:
Rentschler Biotechnologie GmbH
Location:
88471 Laupheim
Temporary:
No
Part-time:
No