Senior Associate Scientist

at  Johnson Johnson

Janssen Sciences Ireland is recruiting for a Senior Associate Scientist, 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.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

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, New Product Introduction (Technology Transfer), Process Validation, providing technical support for Manufacturing investigations and Health Authority Inspections.

EDUCATION:

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

• 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 product development activities 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 “man 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.