Job Information
J&J Family of Companies Scientist Biotherapeutics in Cork, Ireland
Scientist Biotherapeutics - 2406181543W
Description
Johnson & Johnson is currently seeking a Scientist Biotherapeutics to join Therapeutics Development & Supply (TDS) located in Ringaskiddy, Cork.
About Johnson & Johnson
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/.
Job Summary:
We have an exciting opportunity for the right person to join our Therapeutics Development & Supply (TDS) API team in Cork in Downstream Process Development or as a product owner for New Product Introduction (Technology Transfer) / Process Validation. The successful process scientist will also provide technical support for Manufacturing investigations and Health Authority Inspections.
Key Responsibilities:
Product owner leading/supporting 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.
Leading/supporting the process development activities at laboratory scale of a control strategy for molecule or unit operation 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.
Designing and executing experimental plans and protocols to support product/process improvements, process validation requirements, technical transfer projects and development activities as required
Provide guidance and leadership for “process fit to plant” activities by offering valuable insights to both process development and manufacturing teams.
Leading/supporting “man in plant” by monitoring the process, providing technical/troubleshooting support during manufacturing campaigns for new products or during process validation campaigns.
Providing technical and scientific oversight as a product owner by Leading / Assisting manufacturing investigations as required, authoring / reviewing events, deviations and CAPAs, authoring impact statements to help meet product release specifications and timelines.
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
Partnering with Project Teams to provide input, review and approval support for regulatory submissions and support subsequent health authority inspections
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.
Qualifications
Education:
PhD or MSc in Biology, Pharmacy or similar field.
6 years industrial experience within a regulated biologics or pharma industry
Extensive biological process development or technology transfer with clinical / commercial manufacturing experience, either cell culture (upstream) and/or purification (downstream).
Experience and Skills:
Required:
Excellent communication, skills, both oral and written.
Demonstrated technical capability with strong technical writing skills with attention to detail
Self driven and capable of planning and performing experiments or projects steps with little to no supervision.
Ability to work well independently 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 with a deep technical interest in biologics and manufacturing.
Preferred:
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.
Primary Location Europe/Middle East/Africa-Ireland-Cork-Cork
Organization Janssen R&D Ireland (7566)
Job Function Biotherapeutics R&D
Req ID: 2406181543W