Exp Sci Biotherapeutics RD

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:
Ringaskiddy, Cork, Ireland

Job Description:

Position Title: Experienced Scientist, Therapetics, Development & Supply (TDS)

Department: TDS-AD Cork

Report to: Associate Manager, Bioassay, Bioassay and Avanced Therpy Stability Sciences

Location: Cork

Travel: 5-10%

Global Compensation Framework Band Number: 25

Company Summary: Johnson and Johnson Innovative Medicine (formerly Janssen Sciences Ireland UC) is a pioneer in the use of mammalian cells to manufacture monoclonal antibodies. 

TDS Analytical Development Cork (TDS) Aanalytical Develeopemt (AD) is a department responsible for clinical release and stability testing for drug substance and drug product and stability management of the large molecule (therapeutic proteins) portfolio.

In addition to clinical release & stability activities TDS-AD Cork is responsible for analytical support for large molecules through troubleshooting, investigations, manufacturing support and analytical method transfer.

In addition to a range of therapeutic molecules (e.g.

monoclonal antibodies, Bi-specifics), J&J has an emerging  Advanced Therapy portfolio (Gene Therapy, Car-T etc).

Position Summary:

Reporting to the Associate Manager, Bioassay TDS-AD Cork, the person will be focused executing analytical procedures for release & stability testing and process characterization for the clinical pipeline.

The successful candidate will also be responsible for the resolution of testing related  issues in support of of the Bioassay and Advanced Therapy Stability Sciences team.

Main duties and responsibilities:  

·       Analytical Testing in a GMP laboratory for the purposes of release and stability testing of the clinical porfolio.

·       Provision of technical expertise in support of release, stability & process characterization assays (e.g.

qPCR, ELISA and cell-based assays).

·       Provision of technical support for process impurity assays (e.g.

Residual Host Cell DNA, Residual DNA and residual protein A).

·       Analytical technology transfer, including co-validation/qualification.

·       Perform, design and direct bench experiments as required.

·       Troubleshooting and investigations.

·       Drive continuous improvement initiatives.

·     ...