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R&D Production Team Leader (Generics)

Reference:KS/ALUW-014233
Location: Dublin
Qualification:Masters
Experience:10+ Years
Job Type:Permanent
Salary:Not Disclosed
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Our client is an Irish incorporated generic pharmaceutical company who are part of a wider group, a Belgian group of pharmaceutical companies with focus on the development and manufacturing of pharmaceutical products. They use 3rd Party manufacturers all over the world, all holding valid EU GMP and/or FDA approval. They license out their products to clients all over the world. The team behind the organisation has significant experience within the European generic industry and today these people are focused on bringing this know-how to Ireland & the US. As our client is a young company, their structure and rapid growth offers special challenges to all their employees. They aim to establish a global network of committed licensee’s and distributors to promote and sell their products. They are currently seeking an R&D Team Leader who will report to the Head of R&D & Medical Affairs within the organisation. The successful person shall supervise the R&D production team.

Role Description:
• Develop the R&D Production Team and company principles and process related to R&D Production activities (process optimization, registration batch production, validation batch production, post-launch scale-up projects and tech transfer projects to new CMO’s) together with R&D project responsible, Supply team, Regulatory team and QA team.
• Participate in setting out the short- and long term strategy for the R&D department with Head of Department
• Develop principles for tech transfer contracts
• Contribute to the choice of CMO’s, negotiate terms and tech transfer contracts, as well as manage the partners during the R&D Production phase.
• Manage resources and project teams for R&D Production activities.
• Overall responsible for project progress-, budget- and timeline reporting
• Act as R&D Production Specialist for part of the ongoing projects

Responsibilities:
• To build and evaluate strategies for process, communication and information flow between stakeholders during the R&D Production phase
• To highlight process- and resource bottlenecks, suggest and participate in organizing solutions to improve department workflow
• To report project progress, -budget and timelines and ensure the quality of reporting
• To draft job descriptions for new R&D Production staff, screen candidates, participate in selecting new team members for employment and set team goals
• To allocate projects to the R&D Production staff and manage resources of ongoing projects
• To ensure that the project teams meets the timelines, minimize delays and ensure data quality in company overview files and archives
• To set out the team framework and supervise team in the planning and negotiation of Project budgets and assessment of appropriate project scope
• Act as R&D Production Specialist for part of the ongoing projects.

Education/Qualifications:
• MSc or higher in a life science discipline; Course in Project Management and team leadership is appreciated; Extensive experience with EU and US R&D Production is desired.
• 10 years of experience in a pharmaceutical industry, specifically hands-on experience with pharmaceutical manufacturing and tech transfers.
• Good English skills is a must (written and oral).
• A strategic mindset and a leading Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environment.
• Ability to manage internal and external project teams in person and remotely.
• Ability to understand different working ss and support team members in achieving department goals
• Proven track record in project management or equivalent with knowledge of project management techniques and tools. Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
• Ability to understand and analyze scientific data and results and review scientific documents including drug development reports, publications and regulatory submissions.

If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256




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