Technology Leader

Req #: 1803455
Location:Boudry, NeuchatelCH
Job Category:Manufacturing/Technical Operations
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene International SaRL
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities will include, but are not limited to the following:

• Develop expertise and scientific understanding of key Pharmaceutical Operations and apply this understanding to optimize/improve manufacturing processes. Advise and assist on the definition of Critical Process Parameters (CPP’s) and the development and implementation of control strategies.


• Actively market/advocate the capability of new technologies and approaches. Build business cases to support the development and application of these technologies.  


• Identify, assess and drive forward key innovation opportunities. Transition these new technologies into the Manufacturing environment/sites.


• Mentor, train, and support the manufacturing operation in the application of technologies and sound science.  


• Pilot new technology. Ensure proof of concept, feasibility and pilot projects are carried out successfully. Implement new technologies in the Global Commercial Supply Manufacturing network.


• Perform trials, qualification and validation for manufacturing processes/technologies and/or equipment at lab scale, pilot scale or full scale including writing and reviewing of test protocols and reports.  


• Provide technology support for introduction of new products and the enhancement of existing products.


• Responsible for expanding and continuously updating a scientific knowledge base for new technologies and processes. Actively engages with external bodies to keep abreast of new approaches, technologies and the associated regulatory pathways.


• Advises on Scientific and Business developments (including Technology, Processes, Regulations).


• Assists 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.


• Proactively engage with Manufacturing sites/Development and advocate the use of QbD and best practice.

Skills/Knowledge Required:

• Minimum Bachelor’s Degree in Chemical Engineering, Engineering, or Natural Science.


• At least 10 years’ experience in the Pharmaceutical/Biotechnology industry.


• Experience in the development/application/introduction of new technologies and the regulatory pathway/hurdles (including QbD).


• Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework.


• Excellent technical/scientific skills and knowledge (knowledge of key pharmaceutical unit operations).


• Excellent leadership skills and ability to influence and work across organizational boundaries.


• Effective communication skills, excellent command of English and preferably another European language.

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