Senior Scientist, Drug Product Development - Biologics-2981140820
Description
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, to be located in Malvern, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is 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 independently develop, design and perform process development work 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.
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. Development and implementation of suitable scale-down models representative of the large-scale manufacturing process steps will be a key activity in this role. The candidate will successfully translate lab-scale data into viable manufacturing process parameters. These will become the basis for clinical manufacturing process instructions and validation of commercial manufacturing processes.
Formulation studies will include rational formulation design/selection plus a variety of characterization studies relevant to the stage of development. The ideal candidate will be able to independently interpret relevant analytical data to drive formulation selection and characterization decisions.
The successful candidate will design development 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.
Qualifications
MS with at least 10 years industry experience in Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline OR a PhD with at least 3 years industry experience in Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline is required
Knowledge and experience of biopharmaceutical process design is required; fill/finish operations strongly preferred
Competency at trouble-shooting process issues based on scale-down/scale-up experience is strongly preferred
Understanding and experience with Lifecycle approach to Process Validation is strongly preferred
Experience with formulation development of biologic products is required
Experience with lyophilization process development is preferred
Strong knowledge and experience of technology transfer operations is preferred.
A strong understanding and experience in the application of various GXP and QbD 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 a variety of container-closure systems including vials, syringes and applicable delivery devices is preferred
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J2W:BIO
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Primary Location:North America-United States-Pennsylvania-Malvern
Organization: Janssen Research & Development, LLC. (6084)
Job Function: R&D
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