Principal Scientist Process

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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 – Principal Scientist (PG30 / ST7)

Principal Scientist

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 responsible for 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.


* Accountable for critical process development projects.


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

tech transfer 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 Janssen process development approach.


* Participates in parenteral networking to ensure a seamless transfer of drug product manufacturing processes from lab through pilot to commercial scale.


* Contributes...