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Director External Manufacturing Technical Operations Netherlands,
Posted on : 25 May 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Basic Functions & Responsibility
The Director External Manufacturing Technical Operations is accountable for all technical aspects of reliable compliant and cost effective supply from the contract manufacturing organization supported. This includes technical issue resolution, process monitoring, improvement and change control, technology transfer and validation, technical capacity optimization. The Director ExMTO typically works with a strategically important partner in a highly complex environment.
The Director External Manufacturing Technical Operations:
- Acts as the technical point of contact for a strategic and critically important class A CMO.
- Is part of a team, led by an ExM Operations Director, with representatives from Quality, Supply Chain and Procurement, that acts as the virtual site leadership team for the CMO in ExM. This focused factory leadership team is collaborating directly with the external partner s site leadership team, to make sure of compliant, reliable, and competitive supply.
- Will organize the technical interface between Merck and the external manufacturing partner in the area of small molecule drug product intermediate manufacturing.
- Is accountable for the following activities:
- Technical problem solving from an end-to-end perspective
- Process robustness
- Process improvement and change control
- Technical capacity optimization
- Tech transfer in and out, from commercialization to supply, from site to site.
- Technical risk assessment and mitigation
- PPQ, continuous process verification and pro-active process analysis
- Project management, -prioritization and -integration of technical activities in collaboration with the focused factory leadership team and the partner
- Knowledge management
- Is frequently present at the external partners site on the production floor, builds a strong interdependent relationship with his technical counterparts and is able to ( read a site ) assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site and contributes to formulate in partnership with the external partner and the company cross-functional team action orientated and time bound improvement plans.
- Meets, as a member of the focused factory leadership team, with the external partner periodically for Business and Operations Review Meetings.
- Contributes, based on company and ExM strategy, to the development of the annual Plan for the relationship with clear goals and targets.
- Leverages standard tools and best practices from the functional area.
- On an as need basis, engages the right subject matter experts in the MMD Manufacturing Science & Technology Community and MRL.
- Interfaces with up- and downstream internal and external sites to ensure end to end compliant, reliable and competitive supply.
- Minimum MSc in engineering, pharmaceutics or the life sciences.
- Minimum of 10 years manufacturing site experience in the areas of process start up, technical transfer, change control and root-cause analysis or have demonstrated experience in these areas.
- Minimum of 10 years of experience with projects involving tech support across the Internal / External Network
- Strong business acumen, interpersonal and influencing skills.
- Strong organizational and project management skills.
- A quality, compliance, risk management and safety mindset.
- Flexibility and the ability to work collaboratively across cultures, functions, with External Partners and Internal sites
- Technical skills in the areas of engineering, pharmaceutics and chemistry. Knowledge of spray drying considered a plus.
- Deep knowledge of the problem solving methodology, hands-on experience in leading complex investigations implying multiple root cause analysis work streams and ability in writing investigation reports and presenting/communicating investigational progress to the stakeholders and senior management. Black Belt qualification considered a plus.
- Travel will be associated with this position at approximately 25%-50% largely in the EU region.
- Responsiveness and flexibility required as travel need may come up at short notice.
- Our employees are the key to our company s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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