Director, Biotherapeutics R&D

at  Johnson Johnson

Johnson & Johnson Innovative Medicine Research & Development (J&J IM R&D) is recruiting for a Director, Biotherapeutics R&D, Analytical Development, located in Cork.
Within JJ&J IM R&D, the Biotherapeutics R&D organization is accountable for the development, clinical supply, marketed product support and technical LCM of biological pharmaceutical products. Analytical Development Cork is in charge of the Clinical Stability Program Management, Clinical Release and Stability analysis of drug substance and drug product for Large Molecules and local site investigational support.
The Analytical Development Director in Cork will lead a team of approximately 75 J&J employees and 80 contractors, maintaining oversight of internal flex resources and of the outsourced activities. The function has a global reporting line.

EDUCATION:

• Ph.D. or Master Degree in Biochemistry, Biotechnology, or Analytical Sciences or related subject area with 8 years of confirmed experience in biopharmaceutical development or related field.

• Lead the AD Cork department in support of the entire development portfolio.
• Prioritize, innovate, and handle knowledge to deliver outstanding operational performance as well as scientific excellence, in line with the vision and strategy of the global Analytical Development organization.
• Develop and implement the strategy for running development stability programs, data analysis & trending.
• Lead Clinical Release and Stability activities performed at AD Cork and at our development partners.
• Provide regulatory support for IND and BLA submissions.
• Ensure continuous improvement using Process Excellence and Lean methodologies.
• Ensure cGMP compliance of the department.
• Champions innovation.
• Exhibits integrity and trust.
• Values diversity, equity and inclusion,
• Handle the departmental operational and portfolio budget.
• Responsible for hiring and developing the required talent.