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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.

• Clear communication skills.

• Adaptable and flexible.

• Innovative.

• Inclusive facilitative style.

KEY INDIVIDUAL CONTRIBUTOR COMPETENCIES:

• To work as a strategic partner with all other departments within the company.

• Builds strong productive relationships.

• Demonstrates ability to work with teams and individuals.

• Asserts personal ideas and opinions using persuasion to influence others.

• Seeks opportunities to grow and develop professionally.

• Uses best practices to improve business operations.

• Works effectively with people that have diverse styles talents and ideas.

• Attention to detail.

• Good problem solving skills.

• Interface with all site departments as required.

• Excellent interpersonal skills.

• Ability to operate as part of a team is critical.

• Excellent communication skills both written and verbal.

• Holds self accountable for compliant and flawless execution.

• Takes personal responsibility for decisions that successfully build customer value.

• Effectively manages and adapts to change.

• Demonstrates the courage to stand alone on ideas and opinions that differ from others.

• Listens effectively and remains open to other peoples ideas.

• Maintains the highest standards of ethical behaviour.

• Treats people with dignity and respect.

QUALIFICATIONS AND EXPERIENCE:

• A minimum of a Masters or PhD degree Biology Immunology Genetics or related scientific field is required

• A minimum of 5 years experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.

• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

• Demonstrated knowledge and testing experience in an FDA/HPRA approved laboratory.

• Experience in analytical technologies with particular emphasis on Bioassays (Cell based and ELISAs) and process impurity assays.

NOTE: A waiver may be granted in exceptional circumstances for individuals who are not performing those tasks requiring the above qualifications and experience. This would be at the discretion of the QC Team Leader in conjunction with QC Manager.

DESIRABLE QUALIFICATIONS AND EXPERIENCE

• Compliance with the cGMP GMP EHS WWRIM AE/PQC IAPP and other local legal and/or regulatory requirements.

• Strong technical Bioassay knowledge in and experience with QC testing methods and equipment is required.

• Proficient in using Microsoft Office applications (Outlook Excel Word and PowerPoint).

• Be able to work independently with minimum supervision.

• Cooperate efficiently with the different partners.

Significant Safety or Working Considerations:

• All employees are required to comply with the requirements of the companys Environmental Health & Safety Policy Safety Statement associated EHS Procedures local legislation and duties outlined in the site EHS Manual.

  In line with the Safety Health & Welfare at Work Act (2005) all employees are required to:

• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.

• Comply with EHS rules and procedures at all times.

• Understand the potential EHS impact of their activities

• Attend and participate in EHS training as required.

• Use PPE and safety equipment as required.

• Report all incidents accidents and near miss events.

• Report unsafe plant equipment acts procedures or issues.

• Make suggestions to improve health and safety in the workplace.

• Actively participate in work area EHS teams.

• Not turn a blind eye to unsafe acts or situations.

IMPORTANT

This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time or to vary the duties and responsibilities of the position to meet production scheduling or other business needs.

Required Skills:

Preferred Skills: