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Posted: Tuesday, May 9, 2017 12:24 PM

Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Scientist, located in Malvern, PA.
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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Material Science is a department within Pharmaceutical Development and Manufacturing Sciences- Large Molecule Value Stream (PDMS-LM VS). Main responsibilities include:
  • In close collaboration with API and DP technical teams, formulate characterization plans to advance understanding of raw materials in manufacturing processes and formulations including, design, execution and/or lead designed experiments in support of raw material qualification
  • Design and implement risk assessments for raw materials with suppliers and support internal efforts for identification and control of Critical Material Attributes
  • Guide pharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria
  • Collaborate with raw material suppliers and internal partners to establish effective raw materials control strategies based on understanding and importance of raw material in API and DP supporting Janssen manufacturing and CMOs
  • Manage and improve Material Qualification process in close collaboration with partners in procurement, quality and technical operations
  • Develop raw material specifications, e.g., cell culture media, chromatography resins, excipients and adjuvants
  • Support technology transfer and life cycle management of materials used in the clinical and commercial supply chain including technical assessment of supplier-initiated and CMO-initiated changes
  • Review and implement industry and regulatory requirements for raw materials, e.g., ICH guidance
  • Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses
  • Development of effective trending methodologies for raw materials including statistical process control and metrics
  • Support enhanced characterization and data analysis, e.g., latent variable statistical models;
  • Support for supplier audits/selection as required
  • Identify and coordinate analytical characterization with the internal and external labs and perform testing as applicable
  • Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials
  • Ensure the proper and timely preparation of technical reports
  • Participate in project and scientific meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations
  • Ensure compliance with safety, GMP, quality and scientific principles

Qualifications
  • A Bachelors in Chemistry, Biology, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 12 years’ experience OR a MS with at least 6 years of experience OR a Ph.D. degree is required
  • Demonstrated experience in project management is required
  • Demonstrated leadership in providing technical and scientific integration of activities and delivering information across multifunctional groups and sites is required
  • Strong matrix team leadership skills and ability to collaborate is required
  • Knowledge of CMC drug development process is required
  • Demonstrated experience in lean and/or six sigma methodologies and tools is preferred

Primary Location
United States-Pennsylvania-Malvern
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
9334170503

Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=9334170503&lang=en


• Location: Philadelphia

• Post ID: 39484158 philadelphia
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