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Manufacturing Technology Director
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| Reference: | SB/HQ00000577 | Location: |
Dublin |
| Qualification: | Doctorate | Experience: | 10+ Years |
| Job Type: | Permanent | Salary: | Not Disclosed |
Our Client are a global Lifescience company committed to scientific excellence and Research and Development innovation to bring life enhancing products to the global marketplace. Deeply embedded in Ireland for over 30 years, our client has been one of the top employers in the pharmaceutical field. Due to significant business success and new manufacturing strategy, our client is now looking to fill the following position;
Manufacturing Technology Director (External Manufacturing).
The MT Director has responsibility to direct the MT External Manufacturing team by supporting network activities and ensuring manufacturing processes are robust and optimized in Contract Manufacturing Organisations for API, Drug Products, Sterile Manufacturing and Medical Devices.
The MT Director also provides technical and problem solving leadership throughout the External Manufacturing organization, and supports the review of change controls at CMOs.
The MT Director provides a link between API/PD in the assessment of all new products or products being transferred to a CMO. The MT director works with API/PD to ensure any new products being introduced to a CMO are introduced and successfully validated by CMOs.
Operations Management
The role of the MT Director will be to;
- Ensure that immediate and effective support and solutions are provided to CMOs when issues occur and investigations are appropriately completed and closed as rapidly as possible.
- Work with CMOs to ensure Product Robustness plans are in place at CMOs.
- Work with CMOs to implement Operations Excellence throughout their respective processes.
- Ensure that specific productivity targets to increase through-put and reduce costs are achieved.
- Ensure that all transfers are supported and that target transfer times, yields and quality are achieved by the receiving site. Establish product robustness monitoring plans before validation of the transferred products.
Required Qualification(s) and Desired Experience
- Ideally a PhD in Chemistry or Chemical Engineering.
- A minimum of 10 years' experience in a pharmaceutical manufacturing environment in new product / process development / commericalisation environment.
- Direct experience in scale up and technical transfer of processes/ drug product capabilities.
- Demonstrated ability to improve manufacturing processes and innovate.
- Demonstrated ability to influence areas not under direct control to achieve objectives.
- Experience managing technical teams.
- Competency using statistical programs (i.e. Minitab, DOE, SAS).
- Excellent communication and interpersonal skills.
- Ability to work in cross-functional, multi-cultural teams.
- In-depth knowledge of regulatory compliance and drug development process
- Leadership and management skills
- Ability to direct multiple projects.
- Strong analytical and technical writing ability
If you would like further Information you can contact the recruiter directly:
Stephen Boylan | Tel: +353 (0) 1 507 9255
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: info@lifescience.ie | Copyright © 2012 Life Science Recruitment Ltd
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