Analytical Development Manager
Basilea Pharmaceutica Ltd
Basel, Basel-Stadt, Switzerland
vor 3 Tg.
source : Jobg8

We're looking for a candidate to fill this position in an exciting company.

  • Select and manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs)
  • Provide analytical oversight of external vendors for API and finished dose CMC analytical activities for small molecule drug substance (DS) and drug product (DP)
  • Design and oversee the development, validation and transfer of phase appropriate analytical methods for raw materials, in-process control, DS and DP testing and ensure the availability of all required documentation
  • Oversee solid state activities and in-vitro dissolution activities for Basilea's portfolio
  • Participate in the development and revision of product specifications, providing expert level guidance in accord with current regulatory requirements
  • Actively contribute to CMC and project teams, and ensure alignment of analytical activities with the project development plans
  • PhD in Analytical Chemistry or equivalent with 5+ years of experience in a GMP pharmaceutical environment
  • CMC Experience in managing analytical development for small molecule drug substance and drug product at third party vendors
  • Experience with a broad range of analytical techniques and regulatory requirements for characterization of pharmaceutical drug substance including HPLC & GC with a variety of detection methods, spectroscopic techniques, particle size analysis
  • You have full understanding of the chemical, solid state and formulation development of a drug to identify and document critical factors which impact analytical activities
  • Experience with the analytical techniques and US & EU pharmaceutical regulatory requirements for characterization of all compounds used towards a new drug including regulatory submission
  • Ability to strategically plan, organize and manage multiple projects simultaneously with proactive, critical analysis of technical and non-technical problems, taking appropriate actions for resolution, including excellent communication skills at different levels and independent decision making
  • Ability to work both independently and collaboratively in a team environment and to positively resolve conflict, to write clear and concise technical reports and other business correspondence
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