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:

Data Analytics & Computational Sciences

Job Sub Function:

Data Science

Job Category:

Scientific/Technology

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description:

POSITION SUMMARY:

 

Reporting to the QC Manager, this position will be focused on responsible for carrying out tasks and projects related QC Technical Team activities at Janssen Sciences Ireland UC (JSI) as required by Good Manufacturing Practice (GMP) with particular emphasis on Bioassay (Cell based, ELISAs etc.) and Process Impurity assays. Partner with other departments to ensure that all QC testing activities are completed in an efficient manner.

 

The QC Technical Team are multi functionary team of Specialists and Scientists across Bioassay, Separations, IP and Microbiology with responsibility to ensure that the QC labs provide a compliant cost-effective quality control service to support base business delivery, investigation support, project execution and advancing the technical competencies of QC using innovative solutions.

 

Given the diversifying of the Johnson and Johnson Innovative Medicine (JJ IM) portfolio, this role may include working on a diverse class of molecules/entities including monoclonal antibodies & bi-specific antibodies and beyond.

 

GENERAL SCOPE OF RESPONSIBILITIES:

• Achieves proficiency in JSI QC laboratory methods and procedures.

• Supports QC investigational activities during complex investigations from a Bioassay perspective while managing the communication flow of QC data within QC to Operations.

• Escalate any non-conformances to the relevant area Team Lead.

• Provide SME guidance to QC during activities in relation to Bioassay method validation and technical transfer activities.

• Collaborate with the method development group to ensure alignment between transferring and receiving lab and to increase the technical capability and knowledge of the QC Cork team.

• Troubleshooting of equipment and its associated software.

• Executes and reviews IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use.

• Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.

• Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards.

• QC data collating, trending analysis and reporting.

• Change management for QC Technical Team.

• Is an active member of the QC Technical Team supporting and providing guidance to the wider QC group.

• Provides assistance to other QC group activities as required and communicates relevant issues to the QC Team Leader and Manager.

• Anticipates and plans for future requirements in the area.

• Deals with non-conformances/ deviations in an accurate and timely manner.

• Deputizes for the QC Technical Manager as appropriate.

• Maintains and develops knowledge of analytical technology as well as cGMP standards.

• Identify and implement new technologies in addition to supporting the validation and filing requirements for the identified new technologies.

KEY COMPETENCIES REQUIRED:

• Collaboration and team work.

• Demonstrates leadership on technical issues and knowledge of Bioassays.

• Strategic thinker.

• Problem solving and attention to detail.

• Results and performance driven.

• Coaching and mentoring style.

• Integrity, trustworthiness and objectivity.

• Customer focus.<