Bioassay Experienced Scientist

Bioassay Experienced Scientist W

Description

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

Department: TDS-AD Cork

Report to: Team Lead, Bioassay, Bioassay and New Modality 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 New modality portfolio (Gene Therapy, Car-T etc).

Position Summary:

Reporting to the Team Lead, 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 New Modality Stability Sciences team.

Main duties and responsibilities:

• 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.

Qualifications

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.

Primary Location Europe/Middle East/Africa-Ireland-Cork-Cork

Organization Janssen R&D Ireland (7566)

Job Function Biotherapeutics R&D

Req ID: W