Contractor - Technology Lead Manufacturing Science (m/w/d)

• Be the Technology Leader for Bulk production within the department.
• 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.

• 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.