Sr. Scientist Proteins AD

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Biotherapeutics R&D

Job Category:
Scientific/Technology

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

Job Description:

The Container Closure Integrity (CCI) team is a development laboratory within the global Research & Development organization and operates in the GMP environment of Johnson & Johnson Innovative Medicine Supply Chain (IMSC).

As part of Analytical Development, we provide end-to-end support for biologics and advanced therapy products, including antibodies, cell and gene therapies, and antibody-drug conjugates, across therapeutic areas including oncology, immunology, and neuroscience.

We work closely with R&D and IMSC partners in an international, dynamic, and collaborative environment.

To strengthen our team, we are seeking a Senior Scientist to lead projects for early- and late-phase development programs and commercial products.

You will help advance our center of excellence (CoE) for container closure integrity testing (CCIT) of primary containers, sterile barrier integrity testing (SBIT) of devices and residual seal force testing (RSF), expand laboratory capabilities, and deliver robust, compliant analytical strategies and analytical procedures in a GMP-regulated development environment.

Following comprehensive on-the-job training, you will coordinate projects, lead method development, validation, and transfer activities, support investigations, contribute to regulatory submissions, and provide analytical support for marketed products.

Your Responsibilities:

o Assume a leading role in project coordination, development and validation of CCIT, SBIT and related assays for a variety of container closure systems (CCS) and devices for cell and gene therapy, antibody, and antibody-drug conjugate programs, representing the CCI team across J&J Innovative Medicine.

o Coordinate method development, validation, and transfer activities in accordance with internal guidance and health authority expectations.

o Provide timely scientific support for investigations and other high-priority stakeholder requests with short turnaround...