Janssen Sciences Ireland is recruiting for a Scientist (on-site), located in Ringaskiddy, Cork.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

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Job Summary:

We have an exciting opportunity for the right person to join our Therapeutics Development & Supply (TDS) API team in Cork. This process sciences role may be responsible for leading Process Development in the lab, New Product Introduction (Technology Transfer), Process Validation, providing technical support for M anufacturing investigations and Health Authority Inspections.

Key Responsibilities may include:

• Supporting/Leading Clinical / Process Validation activities for New Product Introduction (Technical Transfer) activities through scientific review of proposed manufacturing processes, technical authoring of protocols/reports, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
• Participate in cross functional teams for the incorporation of process parameters into batch records and associated automation documents to ensure right first time process execution
• Supporting/Leading early and late phase process development activities in the lab through generation of protocols/reports, execution of laboratory scale studies and scientific review of data to understand the science of the molecule and its impact on critical quality attributes .
• Provide guidance and leadership for "process fit to plant" activities by offering valuable insights to both development and manufacturing teams.
• Supporting/Leading "person in plant" by monitoring the process, providing technical/troubleshooting support during manufacturing campaigns for new products or during process validation campaigns.
• Providing technical support by Leading / Assisting manufacturing investigations as required, authoring / reviewing events, deviations and CAPAs, to help meet product release specifications and timelines.
• Partnering with Project Teams to provide input, review and approval support for regulatory submissions.
• Participating in and/ or Leading cross-functional project teams.
• Interpreting project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
• Fostering a culture of Lean principles and Continuous improvement within the department, fostering collaboration with internal and external partners.

Education:

• A minimum of a BSc degree in Biology, Pharmacy or related scientific field is required, advanced degree is preferred.

Experience and Skills:

Required:

• 3 years' experience within a regulated biologics or pharma industry
• Biological process development or clinical / commercial manufacturing experience, either cell culture (upstream) and/or purification (downstream).
• Excellent communication, skills, both oral and written.
• Demonstrated technical capability with strong technical writing skills with attention to detail
• Capable of planning and performing experiments or projects steps with some supervision.
• Be self-driven and keep up to date with regulatory, technical developments within the industry.
• Ability to work well in dependently but also in a cross functional team environment, strong collaboration skills and flexibility.
• Demonstrated ability to adapt to rapid changes in project priorities and requirements .
• Advanced root cause problem solving with strong scientific data driven decision making ability .

Other:

• Language requirements - fluent English
• There may be requirement for occasional travel to other sites.

This is what awaits YOU at J& J:

This is an opportunity to work with a groundbreaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.

We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.

Whether you're one of the people who already work here, or you're considering joining the team, we offer:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.
• Possibilities for further personal and professional development/education
• Excellent Benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .