Experienced Scientist Biotherapeutics

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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

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 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)

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 proteinbased therapeutics across the product lifecycle. This role combines scientific expertise in protein stability with crossfunctional 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 highquality data generation and contribute to CMC and regulatory submissions.

• Lead the design execution interpretation and reporting of stability studies for protein therapeutics

• Develop scientifically sound stability strategies to support shelflife 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 crossfunctional project teams

• Partner with analytical teams to ensure stabilityindicating 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 & Johnsons 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

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.

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The anticipated base pay range for this position is:

Benefits:

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 locations 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.

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