Contractor - Technology Lead Manufacturing Science (m/w/d)
Skills: bulk production, biologics
MS&T is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes. We work across the entire lifecycle of our Pharmaceutical Products and across both internal and external manufacturing and API Manufacturing.
Regulatory Agencies are strongly advocating that Industry develops a more fundamental understanding of Manufacturing Science and is encouraging the introduction of new technologies, such as PAT and Continuous Manufacturing, to improve quality and reduce the production costs of medicinal products. This role develops expertise in bulk Manufacturing technologies, processes, unit operations and innovative technologies targeted to reduce Manufacturing costs, improve quality, increase process robustness and protect IP.
• 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
• 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.