Senior Scientist, Stability in Somerville, New Jersey | DiversityInc Careers
 
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Senior Scientist, Stability


Ethicon, part of the Johnson & Johnson family of companies, is recruiting for a Senior Scientist, Stability, to be located in Somerville, NJ.

 

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

 

The role of an Ethicon Stability Scientist is to support the activities of the R&D Stability program.  This includes stability study design and reporting to support New Product Development (NPD).  It also includes Life Cycle Management (LCM) studies to support changes to site manufacturing, materials and packaging; as well as, stability program facilitation for other sites and Third-Party Manufacturers (TPM).

 

Duties and Responsibilities:

  • Deploy and sustain stability best practices toward successful development and manufacture of medical devices and combination products.
  • Provide leadership/representation on multidisciplinary project teams as a Global Product Stability Group expert and a stability study director. Author stability strategies and protocols as needed.
  • Maintain stability program procedures, work instructions, and templates.
  • Ensure environmental chambers are maintained in accordance with FDA requirements.
  • Ensure documentation in support of expiry dating is in alignment with company, industry and regulatory guidelines.
  • Partner with other functions (e.g. Operations, Regulatory Affairs, Quality) to identify and correct any product or process-related issues.
  • Embrace a team-oriented environment conducive to change, appropriate risk-taking, and flexibility.

Qualifications
  • A Bachelor of Science and a minimum of 2 years of medical device or pharmaceutical experience is required. A Master’s degree or PhD is preferred.
  • Previous working experience in stability operations and industry best practices is required
  • Experience in a GMP regulated environment is required
  • Knowledge in medical device regulations, standards, and guidance’s is preferred  
  • Experience creating Stability protocols and reports in LIMS is required
  • Experience working in QC/QA laboratory and/or manufacturing cGXP environment is preferred
  • Knowledge of Design/Process Excellence is preferred
  • This position will be located in Somerville, NJ and may require up to 10% domestic travel

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Primary Location
United States-New Jersey-Somerville-
Organization
Ethicon Inc. (6045)
Job Function
R&D
Requisition ID
5989181030