Associate Scientist, Drug Product Development Biologics
Location:
Malvern , Pennsylvania
Posted:
April 02, 2017
Reference:
3672170303-en-us

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an 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.   
 

The Associate Scientist in the Parenterals and Liquids (P & L) group in Drug Product Development will be responsible for performing experimental studies related to the formulation development and testing of therapeutic proteins or other biologics including monoclonal antibodies (mAbs).  This includes the development and optimization of liquid and lyophilized biologics formulations, as well as execution of characterization plans and stability studies.  Additional responsibilities include but are not limited to the following:

 

  • Designing and optimizing various formulation and filling unit operations including freeze/thaw, mixing, sterile filtration, vial and syringe filling and lyophilization
  • Participate in overseeing the execution of pilot to commercial scale fill/finish manufacturing processes. 
  • Design and manage non-GMP stability studies on experimental and target formulations
  • Perform studies to evaluate the chemical and physical compatibility of formulations with container/closure components, manufacturing, and administration equipment
  • Perform technical analysis of the project data, including trending of data, and may be expected to present data to peers and functional management
  • Author technical reports and make presentations of technical data
  • Follow general laboratory safety procedures, as related to biologically-derived materials
  • Collaborate with contacts inside the company including functional line management as well as scientists in related functional areas such as Research and Development, QC/QA, Clinical, Manufacturing, Toxicology, and Regulatory (CMC)
  • Perform her/his duties consistent with good laboratory practices

Qualifications
  • B.S. in an appropriate scientific discipline with at least 2 years of related laboratory experience OR an M.S. with at least 1 year laboratory experience is required
  • Pharmaceutical and/or Biotechnology experience is preferred
  • Demonstrated experience with formulation and fill/finish process development for therapeutic protein and/or biologic products is required
  • Working knowledge of GLP and GMP requirements are preferred
  • Experience with characterization of biological molecules and development of analytical methodologies for characterization of drug product attributes is preferred
  • Working knowledge of numerous biochemical, biophysical and analytical methodologies (ie:  HPLC, fluorescence and UV spectroscopy, particle analyzers, etc.) is required
  • Experience with aseptic process validation, scale up and technology transfer of liquid and lyophilized dosage forms is preferred
  • Familiarity with pharmacy procedures for drug preparation and human administration is preferred

Primary Location
United States-Pennsylvania-Malvern
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
3672170303

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.

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