HireDiversity

Radnor, PA, US

PRINCIPAL SCIENTIST- BioProcess-5838121220

Description

Janssen Pharmaceutical Research and Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Level Bio Process Engineer IV Protein Formulation & Fill/Finish to join our Parenterals & Liquids Group (PLG), in Drug Product Development, PDMS located in Radnor, PA.

Janssen R & D, LLC' develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Janssen has brought critical biologic therapies to patients suffering from debilitating immune disorders.

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

Basic Function

Utilizes a broad understanding of the entire development process and scaling principles to design and transfer drug product manufacturing processes. Oversees clinical drug product manufacturing and Process Validation activities. Responsible for developing and conducting laboratory studies without supervision. Designs experiments and interprets experimental data. Makes independent decisions. Involved in process improvements to the business. Serves as a lead for projects or initiatives with significant business value.

Specific Duties

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.

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. The candidate will successfully translate lab-scale data into viable manufacturing process parameters. These will become the basis for clinical manufacturing process instructions and Process Validation.

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 interpret relevant analytical data to drive formulation selection and characterization decisions.

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.

Designs entire scientific strategy (big picture view) to meet project goals. Supports various customer needs for projects. Originates significant process improvements and leads team effort.

Influences internal groups, both scientifically and strategically. May lead internal projects or initiatives with significant local impact.

Qualifications


BS/BA with 13 years experience, M.S. with 11 years experience, or PhD with 7 years experience in Chemical Engineering, Biological or Pharmaceutical Sciences, or a related Scientific or Engineering discipline.
Knowledge and experience of biopharmaceutical process development is required (fill/finish operations preferred). Competency at trouble-shooting process issues based on scale-down/scale-up experience is strongly 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. Experience with lyophilized formulation development and process development of lyophilized products is a plus. Experience with a variety of container-closure systems including vials, syringes and applicable devices is a plus. Influences internal groups, both scientifically and strategically. May lead internal projects or initiatives with significant local impact is required.

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Primary Location:North America-United States-Pennsylvania-Radnor
Organization: Janssen Research & Development, LLC. (6084)