Opportunity to work as Stability Integrator @ Johnson & Johnson
Job Description
Requisition ID: 0000155S
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Stability Integration Specialist in Raritan, NJ, Titusville, NJ, Beerse, BE, Guaynabo, PR, or Higi, India.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world. With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Global Stability Operations is a department within the Janssen supply chain, responsible for the stability management of pharmaceutical products and active pharmaceutical ingredients manufactured in the different manufacturing sites worldwide and for the site-to-site analytical method transfers within Janssen Supply Chain (JSC).
The Stability Integration Specialist will:
Be responsible for Stability Management of Drug Substance/Drug Products and site-to-site Analytical Method Transfers within JSC.
Handle Stability and Analytical Transfer Management of a portfolio of products.
Be the first point of contact for stability and transfer related issues and lead for escalating stability OOT/OOS (out of tolerance/out of scope).
Trend and profile product behavior.
Support and coordinate investigations.
Perform Scientific and Quality evaluation of generated results.
Draw up conclusions on shelf life/ retest period, storage conditions and instructions, shipment excursions and method transfer status.
Assure resources are planned (e.g., stability storage conditions and space, equipment, reagents, people, skills, etc.).
Coordinate Safety Health & Environmental (SHE) assessments of new chemicals and reagents for the stability testing labs.
Assess readiness of the stability group for New Product Introductions (NPI).
Participate in projects as stability expert.
Ensure compliance with all relevant regulations, guidance, compendial requirements for stability studies, analytical methods and specification.
Qualifications
A minimum of a Bachelor’s degree or equivalent degree is required
A degree focused in Science, Pharmacy or Industrial Engineering is preferred
A minimum of 4 years of relevant experience is required
Strong knowledge of related domestic and international Stability guidelines for the Pharmaceutical/OTC business is required
Experience facilitating or contributing to method transfers is required
Advanced computer skills and experience with MS software applications (Word & Excel) are required
Experience with Minitab, LIMS and Trackwise are preferred
Good knowledge of statistical data analysis is required
Project management experience and related certifications (PMP, FPx, etc.) are preferred
Experience working in a large enterprise, global environment is preferred.
This position will be based in Raritan, NJ, Titusville, NJ, Beerse, BE, Guaynabo, PR, or Higi, India and may require up to 5% travel.
Posts
