Principal Scientist, Large Molecule Drug Product Process Development - Malvern, United States - Johnson & Johnson

Johnson & Johnson Malvern, United States

1 week ago

Description

Johnson and Johnson is recruiting for a Principal Scientist, Large Molecule Drug Product Process Development in the Biotherapeutic's Drug Product Development and Delivery organization (Global Process team) located in Malvern, PA.

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

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

They 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.
Provides scientific and strategic leadership to new product introductions for fill finish processes to external or internal Janssen manufacturers.
Partnering with MSAT, Manufacturing Site leads, Quality, Regulatory, and other functions for flawless introduction of manufacturing processes into production sites.
Transfer of the process to the supply chain network in accordance with pertinent regulatory guidelines.
Lead best product and process at launch, right first time and other technology transfer harmonization/optimization initiatives.
Must have knowledge of drug substance and/or drug product process.
Work closely with the formulations and primary container and device teams to ensure end to end process alignment.
Ability to work independently and have strong communication skills.

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