Senior Associate Scientist, Analytical, Large Molecule Material Science
Location:
Malvern , Pennsylvania
Posted:
March 16, 2017
Reference:
4275170308-en-us

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior Associate 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, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 9 years of experience OR a Masters in Chemistry, Biology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 6 years of experience is required
  • Demonstrated proficiency in assay method development and optimization for trace metals using ICP-MS for raw materials, chemically defined media and in-process samples for upstream, downstream and formulations is required
  • Expertise in troubleshooting of ICP-MS instruments and knowledge of sample digestion procedures is required
  • Demonstrated proficiency in understanding and application of ICP-MS KED (Kinetic Energy Discrimination) and/or DRC (Dynamic Reaction Cell) modes is required
  • Demonstrated proficiency in assay method development for techniques including NMR, GC/MS, UPLC, LC/MS, other spectroscopic techniques, e.g., Raman, NIR x-ray fluorescence, and chromatographic separations is strongly preferred
  • Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is preferred
  • Demonstrated competency and experience in product development within the pharmaceutical industry is preferred
  • Demonstrated competency and experience in use of project management tools (e.g., MS Project), spreadsheet and databases are preferred
  • Demonstrated experience is 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

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.