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Manager Stability & Release Analytics (M/F) - Switzerland
Want to know company name or location? Company managed [?]
Posted on : 12 June 2017
- Our company 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)
- 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 statemen
- Support Analytical R&D to devise appropriate conditions for e.g. stress, in-use, and compatibility testing
- 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 result
- 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.