Principal Scientist Process

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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:

Description:

Johnson&Johnson's Innovative Medicine is recruiting for a Principal Scientist in the Global Process, Biotherapeutic's Drug Product Development and Delivery organization, located in Schaffhausen, Switzerland.

At the Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives.

We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

And we pursue the most promising science, wherever it might be found.

The candidate for this position will be leading process development and technology transfer of fill/finish manufacturing processes of biotherapeutic products.

The candidate will also work and partner with colleagues in MSAT, Quality, Regulatory, and other functions to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations.

Primary responsibilities:


* Lead late-stage process development, technology transfer, process validation, and filing activities both to and between manufacturing sites (internal/external network) by providing Scientific support as well as technical project management.


* Responsible for timely authoring of tech transfer documents (e.g.

tech transfer/process validation protocols and reports, criticality analysis and regulatory submissions).


* Supports local or external manufacturers in troubleshooting parenteral products requiring scientific expertise.


* Acts as subject matter expert for scientific aspects of fill/finish manufacturing of parenteral products during internal and external audits.


* Partners with cross functional groups to ensure processes are consistent to accepted J&J IM platforms and are in compliance with the submitted CMC dossiers and general cGMP regulations.


* Provides feedback to development teams about technical performance and consistency with the J&J IM process development approach.


* Participates in par...