- Sep 5, 2023
- 2 min read
- Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
- Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and CVD.
- Lead/manage strategic projects (such as the Technology Transfer of a drug product from Development) from project initiation to closure including after action reviews.
- Advocate best practice project methodologies and tools. Develop, write and review project documentation including project plans, test protocols, risk assessments and reports.
- Provide technical/scientific expertise and support to manufacturing sites. Lead or support product, technology or manufacturing improvements/changes.
- Assist with writing and reviewing of CMC documentation associated with project or manufacturing changes.
- Transfer reliable and well-understood Manufacturing processes into Global Supply or within the network. Transfer the knowledge from the sending unit to receiving unit and Product Steward. Ensure knowledge is captured and transferred.
- Proactively engage with Manufacturing sites/Development and CRO/CMO's and advocate the use of QbD principles. Advise on the definition of CQA's and CPP's and an appropriate control strategy.
- Active participation in the design, execution and data analysis associated technical trials/batches associated with the projects. Writing and reviewing project documentation including project plans, test protocols, risk assessments and reports.
- Responsible for expanding and continuously updating a scientific knowledge base. Advises on Scientific and Business developments (including Technology, Processes, Regulations etc).
- Applies and advocates the use of QbD, Lean and 6 Sigma methodologies.
- Assist with the development of Standards, guidelines and SOP's to enhance the quality and robustness of our manufacturing operations, knowledge transfer and technical support processes.
- Degree in Engineering, Pharmacy or Natural Science.
- At least 10 years' experience in ·experience in Pharmaceutical/Biotechnology development or production.
- Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework.
- Good knowledge of various types of pharmaceutical Manufacturing processes/technologies.
- Excellent knowledge of Technology Transfer and validation.
- Demonstrated project leadership/management experience. Experience of multi-site/cross-site project management.
- Working knowledge QbD, Lean and 6 Sigma methodologies.
- Excellent leadership skills and ability to influence and work across organizational boundaries.
- Effective communication skills, good command of English and preferably another European language.
- Ability to work well as an integral part of a large Project Team.
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- Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
- Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and CVD.
- Lead/manage strategic projects (such as the Technology Transfer of a drug product from Development) from project initiation to closure including after action reviews.
- Advocate best practice project methodologies and tools. Develop, write and review project documentation including project plans, test protocols, risk assessments and reports.
- Provide technical/scientific expertise and support to manufacturing sites. Lead or support product, technology or manufacturing improvements/changes.
- Assist with writing and reviewing of CMC documentation associated with project or manufacturing changes.
- Transfer reliable and well-understood Manufacturing processes into Global Supply or within the network. Transfer the knowledge from the sending unit to receiving unit and Product Steward. Ensure knowledge is captured and transferred.
- Proactively engage with Manufacturing sites/Development and CRO/CMO's and advocate the use of QbD principles. Advise on the definition of CQA's and CPP's and an appropriate control strategy.
- Active participation in the design, execution and data analysis associated technical trials/batches associated with the projects. Writing and reviewing project documentation including project plans, test protocols, risk assessments and reports.
- Responsible for expanding and continuously updating a scientific knowledge base. Advises on Scientific and Business developments (including Technology, Processes, Regulations etc).
- Applies and advocates the use of QbD, Lean and 6 Sigma methodologies.
- Assist with the development of Standards, guidelines and SOP's to enhance the quality and robustness of our manufacturing operations, knowledge transfer and technical support processes.
- Degree in Engineering, Pharmacy or Natural Science.
- At least 10 years' experience in ·experience in Pharmaceutical/Biotechnology development or production.
- Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework.
- Good knowledge of various types of pharmaceutical Manufacturing processes/technologies.
- Excellent knowledge of Technology Transfer and validation.
- Demonstrated project leadership/management experience. Experience of multi-site/cross-site project management.
- Working knowledge QbD, Lean and 6 Sigma methodologies.
- Excellent leadership skills and ability to influence and work across organizational boundaries.
- Effective communication skills, good command of English and preferably another European language.
- Ability to work well as an integral part of a large Project Team.
Prinicpal Scientist - Suisse, Schweiz - Consultants in Science Sàrl
vor 4 Wochen
Beschreibung
Prinicpal Scientist - MS&T
We are looking for a Principal Scientist to lead and/or manage global and strategic projects for our client's Global commercial supply.
The Company
The Role
You
Our client is looking for someone who has:
***This position has now been filled, please contact be informed of future similar positions***
We are looking for a Principal Scientist to lead and/or manage global and strategic projects for our client's Global commercial supply.
The Company
The Role
You
Our client is looking for someone who has:
***This position has now been filled, please contact be informed of future similar positions***
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