Johnson & Johnson Careers

Senior Scientist, Drug Product Development Biologics (1 of 2)

Malvern, Pennsylvania
R&D


Job Description

Requisition ID: 3105180927

Janssen Research & Development, L.L.C., 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 candidate will independently develop, design and perform formulation development and characterization in support of formulation, process and fill-finish activities for vaccines and other biologic/cell therapy drug products.
 
Major Duties and Responsibilities to Include:
  • Design and execute formulation development experiments for oncolytic viruses and other biologic drug candidates (including vaccines and monoclonal antibodies), including rational formulation design/selection plus characterization studies relevant to the stage of development.  Studies include, but are not limited to, biophysical characterization, stability, composition selection and robustness and development of administration protocols.
  • Design and execute process development studies to determine and characterize process parameters associated with preparation of drug products for oncolytic viruses and other biologic drug products.  Studies include, but are not limited to, freeze-thaw, mixing, filtration, pumping, filling, biophysical characterization, stability, composition robustness and lyophilization.
  • Design and execute studies to understand how the drug product interacts with the product contact material surfaces during fill/finish manufacturing and during dosage preparation and delivery of oncolytic viruses and other biologic drug products.
  • Lead or participate in technology transfer of fill finish process to internal sites or CMOs.
  • Prepare documents for regulatory filings (IND, IMPD, BLA, MAA) and internal company use. Design experiments and provide relevant data to support responses for regulatory agencies   minor deficiency letters.
  • Lead or 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 in Pharmaceutical Sciences, Chemical Engineering or related scientific discipline, with at least 10 years industry experience in Pharmaceutical, Biopharmaceutical, Chemical or related industry OR a PhD in Pharmaceutical Sciences, Chemical Engineering or related scientific discipline, with at least 3 years industry experience in Pharmaceutical, Biopharmaceutical, Chemical or related industry is required
  • Knowledge and experience of biopharmaceutical formulation and process design is preferred
  • A strong understanding and experience in the application of various GXP and QbD concepts is preferred
  • Experience in biologics and live virus product formulation and development is preferred
  • The ability to develop, document and analyze experiments that significantly contribute to process and material knowledge is required, including discerning and communicating testing outcomes effectively with cross-functional teams
  • Technical writing skills, including the ability to maintain high quality documentation and prepare reports, SOPs or other technical reports is required
  • Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, and particle methods) and biophysical techniques is preferred
  • Familiarity with a variety of compendial references including United States Pharmacopeia 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 contact surfaces 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
3105180927