J&J Family of Companies SENIOR ASSOCIATE SCIENTIST in Cork, Ireland
Position Title: PDMS CRS Bioassay Senior Associate Scientist
Department: PDMS CRS
Report to: Team Lead, Bioassay and ED 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.
Clinical Release & Stability is a department of Pharmaceutical Development and Manufacturing Sciences – Analytical Development (PDMS-AD). The department is responsible for Tox release testing, Clinical release and stability testing for drug substance and drug product, chamber and sample handling and stability management. The Clinical Release & Stability department in Cork, Ireland, is responsible for analytical support for large molecules.
Reporting to the Bioassay Team Lead in the Clinical Release and Stability Dept., the person will lead and advise on various projects, focused on biological assays and associated analytical techniques, and testing issues in support of clinical release and stability testing.
Main duties and responsibilities:
• Provision of expert bioassay technical support in CRS.
• Provide technical leadership to the bioassay area personnel.
• Analytical technology transfer, including Bioassay co-validation/qualification.
• Perform, design and direct bench experiments as required.
• Troubleshooting and investigations.
• Drive continuous improvement initiatives, including bioassay optimisation.
• Technical coaching/training of area personnel.
• Technical liaison with Bioassay Method Development Group, external vendors and 3rd level institutions/relevant government bodies.
• Remain current with regard to cell biology, Bioassay methodologies
technology and equipment, membership of relevant professional bodies.
• Independently write SOP’s, protocols, reports and IMPD/IND regulatory filing documents.
• Supports the Manager for anticipating and planning future requirements in the area
• Contribute to area management operational and strategic initiatives.
• Presents technical analytical data clearly and concisely to customers i.e. internal and external regulatory inspections.
• Ensure compliance with applicable cGMP and other business compliance regulations.
• Participate in risk assessments, inspections, audits, etc. and implement and follow-up CAPA’s assigned.
Key Skills and Competencies required:
• Expertise in cell biology/cell culture/cell based and binding Biological Assays.
• Analytical Technology Transfer (equipment procurement and qualification, bioassay method qualification/validation).
• Strong problem solving skills (green belt level).
• Proficient in Bioassay data reduction, reporting and statistical analysis (biostats).
• Experimental design, including DOE, bioassay development.
• Automation and 5S.
• Very strong communication skills (verbal, written & presentation).
• Project management.
• Lean labs.
• Familiar with applicable cGMP and other business compliance regulations.
• Demonstrate capabilities in strategic thinking.
• 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 Masters or PhD degree in Cell/Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
• Practical analytical laboratory experience in a GLP/GMP environment is advantagous.
Janssen R&D Ireland (7566)