5065
Associate Director
Cork, Ireland
Life Science
Permanent
5065
Posted on:
January 27, 2025
The Highlights:
- Join a dynamic and innovative Pharmaceutical leader
- Extensive progression potential
- Improvement initiativities
The Role:
Elusav recruitment have an exciting opportunity for an Associate Director, Drug Substance Technology Transfer with a leading Global Biopharmaceutical in Cork, Ireland.
As the Associate Director, you will provide technical and scientific leadership to the Manufacturing Network through partnerships with global functions and third-party Commercial Manufacturing Organisations (CMOs) to introduce new products and technologies across our internal and external networks.
Job Responsibilities:
- Accountable for the project execution and delivery of successful process characterisation, engineering, process performance and support to regulatory filing across all modalities.
- Driving excellence in Tech Transfer execution for Drug Substance.
- Project Portfolio Ownership.
- Being the primary interface between Manufacturing Operations (Drug Substance) and the Drug Substance Technology wider team for Technology Transfer and LCM.
- The delivery of Technology Transfer across our Manufacturing Network and successful handover to the operations team.
- Supporting the development and execution of the Strategy through Tech Transfer for the operational site.
- Successful Partnership with Technical Development & Services and Operations in the delivery of the product development pipeline and commercialisation strategy.
- Lead a team of scientists and engineers in the delivery of TT for Drug Substance across our Manufacturing Network.
- Manage and communicate the project portfolio to key stakeholders.
- Identify, recruit, develop and retain qualified individuals to lead Tech Transfer for our Manufacturing Network.
- Create and maintain an environment of teamwork and collaboration while developing and motivating a high-performing team that models the organisation values and attributes.
- Serve as an influential member of the Biologics Centre of Excellence, BCoE leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions.
- Partner with BCoE leadership to provide technical expertise and discussion during GMP audits from regulatory authorities.
- Ensure personal understanding of all quality policy system items that are per training curriculums.
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
- Participate in Global Partner Teams and CMC teams as required.
Job Requirements:
- Degree in Engineering, Science or Business Discipline.
- PhD / master’s in science or engineering Discipline is preferable.
- 5+ years of professional experience in the pharmaceutical industry, including managerial experience.
- Demonstrated to lead and develop an effective team of scientists and engineers.
- Proven track record of Technology Transfer in Drug Substance.
- A broad understanding of Drug Product, Small Molecule Devices and a keen sense of business acumen.
- Experience collaborating effectively with other functional groups to achieve business objectives.
- Effective decision-making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.
- Demonstrated initiative; results oriented, initiative to institute change.
- Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
If you would like to learn more about the vacancy, apply now, or contact Brendan Mullins on +353 61 527 150 or Bmullins@elusav.com
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Associate Director
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