Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, headquartered in the heart of the life sciences hub of Basel, Switzerland.
We are an innovative and multinational team of 225 employees worldwide and committed to discovering, developing and bringing to market medicines that make a clear difference to the lives of patients. Our activities are focused on the therapeutic areas of oncology and anti-infectives, with two commercialized drugs in our portfolio (Cresemba® and Zevtera®).
 
In order to strengthen our Technical Operations Department we are looking for an experienced
 

Analytical Development Manager M/F 

Your tasks

  • 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
 

Your profile

  • 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


Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on interesting, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success.

If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application via our careers portal.
Additional information can be found on our website www.basilea.com.