Johnson & Johnson Careers

Senior Scientist, Drug Product Development

Malvern, Pennsylvania
R&D


Job Description

Requisition ID: 2860180926

Janssen Research & Development, LLC ., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior 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.
 
The successful candidate will work in the Biotherapeutics Drug Product Development (DPD) department. The incumbent will develop, design and perform particle characterization in support of formulation, process and fill-finish activities.  Additional duties and responsibilities to include
  • Design and execute experiments to study particle formation in formulations of biologic drug candidates (therapeutic proteins, vaccines and VLP’s) and long acting/controlled release injectables. Added scope will include developing methods (authoring GxP methods) to analyze formulations subjected to freeze-thaw, mixing, filtration, pumping, filling and lyophilization.

  • In addition, the candidate would study the particle formation dynamics of the drug product associated with dosage preparation (ancillaries/diluents) and delivery to the patient

  • Experience with studying particle formation in various delivery systems including but not limited to controlled release, nanotechnology, encapsulation, long acting injectables.

  • Prepare documents for regulatory filings and internal company use. Design experiments and provide relevant data to support responses for FDA minor deficiency letters.

  • Participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions and successfully resolve problems with suppliers, methods, project issues and deviations.


Qualifications
  • MS with at least 10 years relevant experience in Protein Chemistry, Chemistry, Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline OR a PhD with at least 3 years relevant experience in Protein Chemistry, Chemistry, Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline is required

  • Demonstrated proficiency in a variety of analytical instruments and software utilized for physical and chemical analysis is required

  • Competency at trouble-shooting how particles are generated during various formulation development and process operations is preferred

  • Strong physiochemical understanding of particle formation in therapeutic proteins, vaccines, and long acting injectable systems is preferred

  • Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, cIEF and cSDS) is preferred

  • Familiarity with biophysical techniques such as HIAC, MFI, rheometry (including viscometry), light scattering (SLS and DLS), and interfacial tension is preferred

  • Knowledge of how excipients interact to prevent and/or cause particle formation is preferred

  • Familiarity with a variety of compendial references including United States Pharmacopeia is required

  • Experience maintaining high quality documentation, analyze and properly interpret data, and prepare reports, SOPs or other technical reports is required

  • Technical writing and data analysis skills is preferred

  • Knowledge and experience of biopharmaceutical formulation, process design and fill/finish operations is preferred

  • A strong understanding and experience in the application of various GXP and QbD concepts is preferred.

  • Experience with developing and authoring GxP analytical methods associated with the measurement of particles in various stages of pharmaceutical development is preferred

  • Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices and how proteins/biologically derived substances interact with the closure surface is preferred

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-Pennsylvania-Malvern
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
2860180926