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.