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Senior Scientist, CMC Job (Radnor, PA, US)

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Johnson & Johnson companies are equal opportunity employers.

Senior Scientist, CMC-9762131017

Description

Janssen Research & Development LLC, a member of the Johnson & Johnson family of Companies, is recruiting for a Senior Scientist position, 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.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The candidate will apply an understanding of protein chemistry to elucidate protein degradation pathways and characterize structure / function relationships in the context of the chemistry, manufacturing and controls requirements for biologics. Specifically, the candidate will be involved with the generation, isolation, and structural characterization of protein degradants for elucidation of degradation pathways and will work with other groups to coordinate the functional characterization of protein variants by various bioassays. The candidate will use the data generated to participate in discussions regarding the classification of isolated protein variants as active drug substance or inactive impurities to support decisions regarding the overall control strategy. Communication of results and representation to cross-functional project teams is necessary, and writing analytical sections of regulatory submissions is expected. The individual will need to maintain laboratory notebooks in a GLP compliant manner and prepare written protocols, reports and SOPs.

Qualifications


A Ph.D. in analytical chemistry, biochemistry, biotechnology, protein formulations, chemical engineering, or a related field with a minimum of 5 years of relevant industry experience, OR a M.S. with 10 years relevant experience is required

A strong knowledge of protein chemistry, degradation pathways, and hands-on experience with protein separations methods (reverse-phase, ion-exchange, size-exclusion HPLC, cSDS/SDS-PAGE, cIEF/IEF) is required

Experience working with other methods for protein structural and functional analysis is preferred

Experience and understanding of pharmaceutical development chemistry, manufacturing, and controls (CMC) processes and regulatory requirements for protein biologics is preferred

Experience working in a GLP/GMP environment is required

The ability to balance and contribute to multiple project priorities is necessary Strong written and verbal communication skills are needed

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W: LI NA

J2W:BIO

J2W:MZ

J2W:NSJ

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

Job: R&D

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