Johnson & Johnson Careers
Requisition ID: 1805705656W
Position Title: BioTD-AD Bioassay Associate Scientist
Report to: Team Lead, Bioassay, Bioassay and Early Development Stability Sciences
Janssen Sciences Ireland UC is a member of the Johnson & Johnson Group of companies and is a pioneer in the use of mammalian cells to manufacture monoclonal antibodies. At its facility in Cork.
BioTherapeutics Development Analytical Development Cork (BioTD-AD Cork) is a department responsible for Tox release testing, 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 BioTD-AD Cork ais responsible for analytical support for large molecules through troubleshooting, investigations, manufacturing support and analytical method transfer.
Reporting to the Team Lead, Bioassay BioTD-AD Cork, the person will be focused executing bioassays and process impurity assays used in the release and stability testing of the large molecule clinical pipline. while being responsible for testing and resolution of product related issues in support of the Bioassay and Early Development Stability Sciences team.
Main duties and responsibilities:
- Routine release and stability testing of binding assays (e.g. ELISA and TR-FRET), cell based bioassays (e.g ADCC assays), process impurities and identity assays for pre-clinical and clinical product development.
- Execution of process impurity assays (e.g. residual host cell protein (HCP), residual DNA (PCR techniques) and residual Protein A).
- Completion of documentation in adherence to GMP.
- Testing to support assay validation/qualification and other studies.
- Laboratory support activities (e.g. reagent qualification), routine passaging of cell lines and general housekeeping.
- Support other projects as assigned, e.g.continuous improvement, automation and operational excellence
- Support troubleshooting and investigations.
- Perform Data Trending to support investigations, demonstrate method capability and product profile.
- Write SOP’s, protocols, work instructions and training modules.
- Other duties as assigned by team lead.
Key Skills and Competencies required:
- Practical analytical laboratory experience in a GLP/GMP environment is advantagous.
- Experience of Bioassay/Cell Culture experience is advantagous .
- 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 Degree in Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
- Knowledge of computer programs such as MS Word, Excel and Minitab.
- Good understanding of quality and attention to detail.
Janssen R&D Ireland (7566)