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Enterprise Management

Associate Director

  • 標題 Associate Director
  • 功能 Enterprise Management
  • 子功能 R&D Management
  • 類別 Senior Manager, R&D Management (PL8)
  • 位置 Cork, Ireland
  • 刊登日期
  • 參考 2406186247W
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描述

Location: Janssen Sciences Ireland, Ringaskiddy

Reports to: BTDS API Manager

Janssen Sciences Ireland (JSI), UC is recruiting for an Associate Director with the TDS API department, located in Barnahely, Ringaskiddy, Cork.

This is an exciting opportunity for the right person to join our Therapeutics Development & Supply (TDS) API team in Cork! This role will support process development projects and manufacturing operations at JSI. The successful candidate will be responsible for leading Process Development, Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.

Key Responsibilities:

  • Leading and mentoring a team of Scientists, working with them in both teams and 1:1 environment, to support their technical responsibilities, their career development and their work/life balances. Fostering a Credo based culture within the team at all times.
  • Lead laboratory operations including scheduling and coordination of execution of activities and setting priorities for experimental work.
  • Providing resources, strategic and technical leadership on a wide range of technical projects led /supported by the laboratory, ranging from NME process development, tech transfer activities, process validation, process technologies and analytics or production trouble-shooting.
  • Leading or mentoring scientists with process development at laboratory scale of late phase programs developing a control strategy for a molecule or unit operation
  • Contributes to the design of experimental plans and protocols to support product/process improvements, process validation requirements, technical transfer projects and development activities as required.
  • Providing technical and strategic leadership with transfer of new process and technologies to both the laboratory and manufacturing suites
  • Collaborating closely with both local and international TDS leadership to ensure the broader strategies of the function are interpreted and implemented in an appropriate manner in Cork.
  • Providing ongoing priority support to JSC Cork operations including serving as a SME for Cork Operations during Regulatory Inspections and Compliance Audits.
  • Developing the functional budget and ensuring that the TDS-API laboratory team operates within the approved budget.
  • Collaborate cross functionally with our MSAT, Operations and Quality colleagues to support LCM programs, projects and investigations as required
  • You will work with your team and peers to ensure departmental adherence to all relevant environmental, safety and health procedures

資格

Education:

  • M.Sc. or Ph.D degree in life sciences (Microbiology, Biochemistry), Chemistry, Engineering or Pharmacy required or Bachelor’s degree with extensive technical experience in a similar role.

Experience and Skills:

Required:

  • Strong theoretical and practical expertise in cell culture, harvest and purification, focused on new product/process development, scale up and technical transfer of manufacturing processes.
  • Minimum of 10 years proven industry experience required within a biopharmaceutical FDA/cGMP manufacturing or related environment.
  • Extensive knowledge of CMC and supply chain with a focus on process development and lifecycle.
  • Solid understanding of Quality & Compliance / regulatory requirements (GMP (Good Manufacturing Practice) / EHSS (Environment Health Safety and Sustainability) for the protein platform.
  • Demonstrate strong data-driven decision making and problem solving capabilities

Preferred:

  • Proven track record in leading technical /scientific team(s) and direct people leadership experience
  • Ability to create a result-oriented (project) team
  • Ability to navigate complexity and change.
  • Ability to interact at various levels of the organization (including Sr. Management)
  • Ability to work under pressure, handle conflicting interests, and take decisions

Other:

  • Language requirements – fluent English
  • Travel percentage – 10%

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 exciting 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

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