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.

· Technical coaching/training of area personnel.

· Technical liaison/SME for assign assays

· Remain current regarding analytical methodologies, technology and equipment.

Key Skills and Competencies required:

• Expertise in analytical methodologies pertaining to AAV biology and application to gene therapy (e.g. infectivity assays, qPCR and ELISA assays).

• Practical analytical laboratory experience in a GLP/GMP environment is advantageous.

• Knowledge of Biological Safety Containment requirements.

• Analytical Technology Transfer (equipment procurement and qualification, method qualification/validation).

• Strong problem-solving skills

• Very strong communication skills (verbal, written & presentation)

• Project management

• Familiar with applicable cGMP and other business compliance regulations.

• Customer focus and results and performance driven.

• Sense of Urgency.

• Ability to work well within team structures and provide leadership.

Education and Experience:

• A minimum of a Master’s or PhD degree, Virology, Immunology, Genetics or related scientific field is required.

• 5+ years of experience in academia, biotechnology, or pharma industry with a primary focus on understanding AAV biology.

• Knowledge of computer programs such as MS Word, Excel and Minitab.

• Good understanding of quality and attention to detail.

Exp Sci Biotherapeutics RD

Job Description