Johnson & Johnson Careers
Technical Expert QC
Requisition ID: 1905742243W
We focus on change. We use innovation to prevent, treat, cure and stop diseases. Developing a vaccine for HIV, refrigerated drones that deliver medicines to places that are hard to reach or robots that operate, everything we do should have a positive impact on people’s lives, nearby and worldwide.
We take care of our people. We give them the chance to discover, engage, live life to the fullest. We hand you the tools to customize your work life to your own lifestyle. With enough fun and challenges at work but also enough time for you.
As a young professional, you want to grow. We want you
to grow. We offer an international context, filled with opportunities and
programs to broaden your knowhow and experience,
in-depth or beyond.
Technical Expert QC - Bioassay
Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100 acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched
a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
In 2017, Janssen Sciences Ireland UC announced that it is to invest more than €300 million in the expansion of its manufacturing plant that will create more than 200 new jobs.
The Technical Expert QC - Bioassay role is responsible for the following:
•Subject matter expert for the analytical methods associated with process impurity and bioassay testing.
•Acknowledged expert in Lab systems, data analytics, automation and emerging technologies associated with process impurity and bioassay testing.
• Work with our Analytical Development Team to troubleshoot and optimize methods & techniques in relation to expertise area
Key job responsibilities:
• Supporting the QC Team Leader during day to day operations of area.
• Planning for and overseeing laboratory related projects e.g. analytical method transfers, equipment qualification, invalid assay and NC reduction initiatives etc.
• Supports the deployment of robotic technology for use in process impurity and bioassay methods.
• Identifying and proactively driving laboratory process improvements leading to improved efficiency &/or compliance within area.
• Acting as an SME during internal investigations, regulatory inspections & external technical discussions etc.
• Keeping up to date with analytical technology and regulatory / compliance trends.
• Develops training materials to enable sharing of knowledge within team
• Trains / mentors other analysts on specific laboratory processes and/or analytical technology.
• Leads investigations and troubleshooting related to process impurity and bioassay methods.
• Performs routine release test execution as required.
• Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc
• Generates, reviews and approves analytical data associated with analytical method transfers and release testing.
• Supports the generation, review and approval of data required for regulatory filings.
• Provides superior technical support on specific analytical technology.
• Acting as designee for Team Lead and/or Manager.
• BSc Hons (or Higher) in a relevant Science discipline.
• 4-6 years’ experience in a similar role within the biopharmaceutical industry
• Technical troubleshooting and problem-solving skills.
• Advanced planning, scheduling and co-ordination skills.
• Excellent social and communication skills
• Self-driven and keeps up to date with regulatory, technical developments within the industry.
• Focus on patients and customers at all times.
• Prior experience of performing similar functions related to this role e.g., Analytical method transfers and co-validation, test investigations, testing, stakeholder management etc.
• Experienced in Bioassay related test methods e.g. Bioactivity, ELISA, HCP or DNA
• Experience with implementing and using TECAN robotic systems
• Strong Bioassay and Process Impurity testing background including a good understanding of Biopharmaceutical manufacturing and batch release processes.
• Experienced in equipment qualification, analytical method transfers, root cause problem solving and continuous improvement.
• A strong team player who is very customer focused, possesses excellent leadership and testing skills and both stakeholder and project management experience.
• Excellent communication, written and oral
• Acute attention to detail
Janssen R&D Ireland (7566)