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.
The successful candidate will work in the Parenterals & Liquids (P & L) group of the Drug Product Development (DPD) department. The incumbent will develop, design and perform process development work independently to support fill-finish activities. They will perform technology transfers to both internal and external partners, and will support Process Validation activities as required. They may design and execute experiments in support of formulation development of biologic drug candidates. The successful candidate will design workflows and studies, collect, record, and interpret data appropriately. Data will be presented at internal and external meetings. The candidate will be capable of training other personnel on techniques and equipment. He/she will write technical memos with minimal review and keep abreast of scientific developments in relevant fields. New concepts learned in this way will be introduced into the workflow.
Process development studies will include:
Determination and characterization of process parameters associated with liquid and lyophilized fill-finish operations - these will include freeze-thaw and heat transfer, mixing, filtration, pumping, filling and lyophilization
Application of suitable scale-down models representative of the large-scale process will be a key activity in this role
Translate lab-scale data into viable manufacturing process parameters
Formulation studies will include:
Rational formulation design/selection plus a variety of characterization studies relevant to the stage of development
Interpret relevant analytical data to drive formulation selection and characterization decisions.
BS/BA in Chemical Engineering or Pharmaceutical Sciences, or a related Scientific or Engineering discipline with at least 9 years experience OR a M.S. in Chemical Engineering or Pharmaceutical Sciences, or a related Scientific or Engineering discipline with at least 7 years experience OR a Ph.D. in Chemical Engineering or Pharmaceutical Sciences, or a related Scientific or Engineering discipline with relevant experience is required
- Knowledge and experience of biopharmaceutical process design is required; fill/finish operations is preferred
- Competency at trouble-shooting process issues based on scale-down/scale-up experience is preferred
- Strong knowledge and experience of technology transfer operations is preferred
- Experience with Process Validation is preferred
- A strong understanding and experience in the application of various GXP concepts is preferred
- Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, CE, SDS-PAGE, IEF, and particle methods) is preferred
- Familiarity with additional analytical techniques such as DSC, rheometry (including viscometry), light scattering (SLS and DLS), and interfacial tension is preferred
- Experience with formulation development and process development of lyophilized products is preferred
- Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices is preferred
Janssen Research & Development, LLC. (6084)Job Function