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Manager Stability & Release Analytics (M/F) - Switzerland  

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Posted on : 29 June 2017

Project Description

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). 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 of its subsidiary Basilea Pharmaceutica International Ltd. 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

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

We look forward to receiving your online application including your complete documents. For additional information please contact Ms Nadine Pfrüner.