Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Ringaskiddy, Cork, IrelandJob Description:
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
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for an Experienced Scientist, Biotherapeutics R&D to be located in Ringaskiddy, Cork, Ireland (Flex working: 3 days per week onsite required)
Purpose:
We are seeking an experienced scientist to support Biotherapeutics R&D development programs and analytical development activities in TDS AD Protein Therapeutics Stability Sciences & Characterization team Cork. This role will be responsible for delivering stability strategies and studies to support the development of protein‑based therapeutics across the product lifecycle. This role combines scientific expertise in protein stability with cross‑functional collaboration, and regulatory dossier authoring to support the clinical protein therapeutics portfolio.
The role holder will act as a subject matter expert in protein stability, provide technical direction, ensure high‑quality data generation, and contribute to CMC and regulatory submissions.
You Will Be Responsible For:
Lead the design, execution, interpretation, and reporting of stability studies for protein therapeutics
Develop scientifically sound stability strategies to support shelf‑life assignment
Provide input into root cause investigations and risk assessments related to stability issues
Author, review, and approve technical reports, protocols, and stability dossier sections
Act as the stability representative on cross‑functional project teams
Partner with analytical teams to ensure stability‑indicating methods and appropriate study designs.
Establishes effective partnerships with other individuals, departments, and external partners so that TDS AD activities are well understood and coordinated
Communicates effectively so that all relevant stakeholders are kept informed of potential risks, resource requirements and project progress
Ensure stability studies are designed and executed in alignment with global regulatory expectations (e.g. ICH Q1, Q5C)
Contribute to regulatory submissions (e.g. IND, IMPD, CTA, BLA/MAA), including authoring stability sections
Ensure all work complies with internal quality systems, data integrity standards, and applicable GxP requirements
Support regulatory interactions by addressing questions related to stability strategy and data
Contribute to TDS AD departmental strategy, capability building, and implementation of new predictive approaches
Drive improvements in stability study design, data analysis, and reporting efficiency
Stay current with scientific and regulatory developments in protein therapeutics stability
Champion innovative stability designs to increase development efficiency and scientific insight
Encourage a culture of scientific curiosity, experimentation, and learning within the team
Identify and lead continuous improvement initiatives that enhance quality, speed, or robustness of protein therapeutics stability sciences deliverables
Applying Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions and decision-making
Are you ready to join our team? Please read further!
Education and Experience Requirements:
A third level qualification such as MSc/PhD in a scientific/technical discipline
Significant industry experience in biopharmaceutical R&D with demonstrated expertise in protein stability
Proven experience designing and interpreting stability studies for protein therapeutics
Experience supporting regulatory submissions and interacting with regulatory guidelines
Knowledge of FDA, EMA, and other applicable regulatory requirements relevant to biologics and/or pharmaceuticals 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
Technical skills and knowledge in protein stability strategies, stability-indicating analytical techniques, ICH stability guidelines and regulatory expectations, data interpretation, scientific writing and technical presentations, risk assessment and problem-solving
Ability to make sound, data driven decisions
Collaborative mindset with the ability to influence across teams
High attention to detail, quality, and data integrity
Resilient, adaptable, and comfortable managing multiple priorities
Commitment to integrity, inclusion, and the highest standards of ethical behaviour
Benefits:
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Coaching, Collaboration, Conducting Experiments, Data Quality, Drug Discovery Development, Chemistry, Manufacturing, and Control (CMC), Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written ExpressionThe anticipated base pay range for this position is:
€52 400,00 - €82 915,00Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Additional information:
52 400,00 - 94 100,00 EUR Annual
