Stability Scientist

Posted 20 Jun 2022

Bedford, Massachusetts - United States

Req Id 250990

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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:

 

At MilliporeSigma the Stability Scientist will utilize knowledge of product stability, quality fundamentals, regulations, and corporate policies to provide routine assistance and guidance to multidisciplinary teams. Collaborate in the generation of product shelf life strategies and authoring shelf life protocols.

  • Analyze shelf life data, determine product shelf life, and authoring of shelf life reports.
  • Initiate, coordinate, track and maintain shelf life studies.
  • 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 teams at all site 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 and execute a shelf life study assessment of the site to identify key gaps in the current system then 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.
  • Utilize progressive thought process to develop organized strategies, providing educated input and feedback for program development and implementation.
  • Collaborate to develop format and contents of advanced shelf life protocols and matrixes, reports, and necessary documentation for continued program compliance and functionality.

 

Who you are:

 

Minimum Qualifications:

  • Bachelor's degree in Chemistry or other scientific or engineering field.
  • 4+ years of experience in a Quality role in excipients, medical devices, and/or pharmaceuticals.

 

Preferred Qualifications:

  • Expertise in product stability/shelf life.
  • Effectively communicate and establish collaborative relationships.
  • Superior verbal communication and technical writing skills.
  • Ability to organize and maintain a complex program; ability to identify immediate needs and make appropriate decisions for continued functionality.
  • Ability to identify potential compliance issues; experience with development and execution of corrective action plans.
  • Proven ability to address deviations and issues in an organized and timely manner.
  • Computer technical expertise; demonstrated ability to operate complex software programs, collaborate with others for technical development, and identify cost-effective alternatives for program maintenance.
  • Proficient understanding of requirements necessary for product quality including consistency, organization, control, compliance, and due diligence.
  • Experience working successfully in large, complex organizations, balancing daily responsibilities, new assignments, and unexpected issues simultaneously with minimal management oversight.
  • Self-motivated with initiative to propose and implement changes for continuous improvement.

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

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.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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