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Manager Stability & Release Analytics (M/F) Basel Switzerland,  

Basilea Pharmaceutica (company)


Posted on : 19 June 2017

Project Description

Description:
  •  It focuses on products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. 
  • The company uses the integrated research, development and commercial operations to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions.
  •  To strengthen our Technical Operations Department, we are looking for a motivated Manager Stability & Release Analytics (M/F)  


Your tasks
  •  As a member of the CMC team assign and monitor all work orders for stability studies and batch release testing at external partners according to the respective project s need
  •  Establish stability protocols, procure compliant data packages; extrapolate data, write final stability reports
  •  Perform batch tracking for release testing and stability studies
  •  Perform all statistical/trending evaluations for submissions or marketed products
  •  Contribute stability and batch results to regulatory documents, propose shelf-live and stability statements
  •  Support Analytical R&D to devise appropriate conditions for e.g. stress, in-use, and compatibility testing
 

 Your profile
  •  PhD or MSc in chemistry or pharmacy with minimum 5 years of experience in managing stability studies and batch release testing, including marketed products
  •  Proficient in working with external partners
  •  Skilled in setting up and reviewing stability protocols, authoring Stability reports and summarizing batch tracking results
  •  Knowledge in stability evaluation and QC testing related to commercial products
  •  Authoring quality related sections of regulatory documents
  •  Profound GMP knowledge is required, broad experience in analytical test methods is an advantage
  •  Team and customer orientated personality, who is flexible, reliable and self-motivated, with a timely and accurate working attitude
  •  Excellent communication skills, knowing matrix organizations and efficient collaboration with interfaces (e.g. QA, Regulatory Affairs, Technical experts)
  •  Fluent in written and spoken English, German would be advantageous
  •  Good IT-user skills in MS-Office programs and statistical evaluation
   

Offer:
We offer an interesting and varied work environment in a dynamic future-oriented enterprise with a highly motivated team, a competitive salary and benefits.

Locations

4005 Basel Switzerland

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