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BioAssay Senior Associate Scientist, Process Analytical Support (1 of 2)

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Job Description


Janssen Research & Development is recruiting a BioAssay Senior Associate Scientist, Process Analytical Support (2 Positions), located in Malvern, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Within Janssen Research & Development, the Biotherapeutics Development (BioTD) organization is responsible for the development, clinical supply, marketed product support, and life cycle management of chemical and biologic pharmaceutical products. Within BioTD, the Analytical Development group supports method development and validation, release and stability testing, structural characterization, and preparation of regulatory filings. Separations and Bioassays are specifically required for the development of pharmaceutical biologics products.

Be on a team that helps make worthwhile drugs to help patients. Help support innovative Large molecule Biologics development.

Key Responsibilities:
• Conduct execution of Bioassays for biologics drug development
• Thrive in a team setting in a dynamic environment, contribute technical expertise to multiple large molecule programs, be proficient with documentation, and review of analytical and bioassay data
• Demonstrate excellent communication and strong interpersonal skills combined with technical, writing, and organizational skills as well as demonstrated attention to detail and record keeping.
• Address complex problems through the data analysis requiring strong process knowledge and in-depth evaluation of multiple variables.
• Engage in a matrixed team environment and provide mentorship to other lab personnel
• Partnering with various J&J stakeholder groups, such as the API, DPD, LMAD, and Discovery, to ensure adoption and implementation of process improvements, stability, and process validation for the preparation of biologics for clinical trials
• Utilizing project metrics and lessons learned to improve business results and product launch processes in the region.
• Serve as instrument owner and manage equipment qualifications and maintenance
• Complete all electronic lab notebooks, GMP, and safety trainings as required in a timely fashion


Qualifications
Required:
• BA/BS degree in a science-related field or equivalent with a minimum of 4 years of related experience or MS with 2 years of related experience
• Strong background in bioassays including ELISA, FRET, qPCR, plate based biochemical assays, impurity assays, or cell-based potency assays
• Excellence in bioassay troubleshooting and routine instrument maintenance
• Creatively tackling technical problems while meeting project timelines
• Ability to work with a limited guidance to plan, execute, and follow through studies
Preferred:
• Background in protein concentration methods using spectrophotometry, analytical protein A, multiple separation-based technologies (e.g., HPLC/UPLC, cIEF, cSDS, electrophoresis, etc.)
• Experience of assays to elucidate structure-function properties in Biologics Development
Other:
• This role is based in Malvern, PA and may require up to 5% of domestic and international travel.

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
7025191009