Experienced Scientist Empower

Overview

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 .

Job Function

Discovery & Pre-Clinical/Clinical Development Biotherapeutics R&D

Location

Ringaskiddy, Cork, Ireland

Purpose

We are seeking an Experienced Scientist (Empower) to support Biotherapeutics R&D development programs and analytical development activities in TDS AD Cork Separation Sciences. This role will contribute to the execution of biotherapeutic projects, method transfer and validation, and laboratory operations in a GMP environment, while partnering across functions to deliver high-quality, efficient, and compliant outcomes.

Responsibilities

• Day to day Empower systems support and troubleshooting, ensuring that E-tickets are addressed in a timely manner
• Design and development of custom fields
• Build, Design, and release of "Empower" report methods/projects and software updates
• Handle and control Separations data (reference materials, Samples) within "Empower"
• Providing technical support for Investigations and data requests as the need arises
• Develop, author and review of Strategy documents
• Validation Support for installation and qualification of new Lab equipment
• Participate/Lead in Laboratory investigations as applicable
• Communication of Laboratory issues to team lead in a timely fashion
• Take an active role in Continuous Improvement, identify and drive improvement initiatives
• Support execution of Biotherapeutics R&D projects and development programs as a developing individual contributor
• Support method transfer and validation activities
• Initiate and support non conformance, contributing analysis, and providing information for effective CAPA implementation
• Write and review laboratory documents, including technical methods, SOPs, work instructions, protocols, and technical reports as relevant
• Recommend improvements to standard procedures and contribute to a continuous improvement culture within R&D
• Maintain training compliance and perform tasks only after completion of required training on current effective procedures
• Support audit readiness and general laboratory support activities as required
• Contribute as an active member of the team, communicate relevant issues to leadership, and assist with broader group activities as needed
• Coach more junior colleagues in techniques, processes, and responsibilities
• Apply Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions and decision-making

Education and Experience Requirements

• A Bachelor's, Master's, or advanced degree in a scientific or technical discipline is required
• Minimum of 5 year's experience of using Empower Software Development/ Administrative experience with Empower software is desirable
• Experience with Change Management systems
• Experience performing progressively advanced responsibilities at Scientist level is preferred
• Knowledge of FDA, EMA, and other applicable regulatory requirements relevant to biologics and/or pharmaceuticals is required
• Experience in GMP or cGMP laboratory environments, including analytical testing, method transfer and validation is required
• Demonstrated knowledge of scientific theories, principles, and techniques used in biological or pharmaceutical analytical test procedures is required
• Strong written and verbal communication skills and the ability to work effectively across functions are required
• Commutability to Ringaskiddy, Cork is essential

Preferred Experience & Skills

• Acute attention to detail with focus on Data Integrity
• Familiarity with regulatory requirements for E-Systems and Separations technology (HPLC, CSDS, CIEF, UPLC)
• Experience supporting non-conformances, investigations, deviations, and CAPA activities
• Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint
• Strong collaboration, problem-solving, and attention to detail
• Ability to influence, coach, and build productive working relationships across a diverse organisation
• Adaptability, sound judgement, and a continuous improvement mindset
• Commitment to integrity, inclusion, and the highest standards of ethical behaviour

Compensation

€52,400.00 - €82,915.00 (anticipated base pay range)

Benefits

• Annual bonus with set target (% of pay) depending on pay grade / location
• Vacation days
• Parental leave for a minimum of 12 weeks
• Bereavement leave
• Caregiver leave
• Volunteer leave
• Well being reimbursement
• Programs for financial, physical and mental health
• Service anniversary and recognition awards
• Participation in several insurance plans - subject to location specific terms and conditions
• Additional benefits as per local policies and plans