Sr. Stability Study Specialist

Posted 13 Feb 2020

Milwaukee, Wisconsin - United States

Req Id 203240



A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your role:


The proper candidate would be responsible for the development, implementation, and oversite of a stability justification program supporting product claims in the life science market.  The following responsibilities are part of this role:


  • Utilize knowledge of product stability, quality fundamentals, regulations, and corporate policies to provide routine assistance and guidance to multidisciplinary teams regarding and supporting product stability justification.
  • Collaborate with multidisciplinary teams in the generation of product shelf life strategies and authoring shelf life protocols.
  • Analyze shelf life data, determine product shelf lives, and author shelf life reports.
  • Responsible for shelf life study initiation, coordination, tracking, and sample management, including, but not limited to sending samples to external contractors, sample storage in environmental chambers, dispatching samples to QC Lab, and maintaining environmental chambers.
  • Provide expertise to ensure all issues related to product stability, shelf life establishment, and sample investigation are adequately addressed, tracked, and resolved.
  • Apply advanced scientific rationale to resolve non-compliance issues, developing a prioritized plan to track and finalize necessary corrective action(s).
  • Proactively communicate with global Shelf Life team at all site organizational locations to maintain awareness of site activity and needs; act as a representative liaison to ensure issues impacting multiple sites are identified and addressed.
  • Develop, strategize, and execute a shelf life study assessment of the site to identify key gaps in the system.  From assessments, develop necessary program improvements to resolve outstanding issues.
  • Actively seek to improve efficiency and functionality of site programs (best practices), while remaining compliant with industry regulations and corporate policies.
  • Other tasks, as determined and assigned.  


Who you are:


Minimum Qualifications:


  • Bachelor's Degree in Chemistry, Biochemistry, Food Science, or related Life Science


Preferred Qualifications:


  • Master’s Degree
  • 3+ years of experience performing stability study work
  • Leadership experience in a manufacturing, lab, or military setting




What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!


Curious? Apply and find more information at

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.





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