The Principal Scientist – Bulk, leads and/or manages global and strategic (or technically complex) projects for Commercial Supply and ensures projects are delivered within agreed timelines, cost and quality targets. Transfers product knowledge into the Global Commercial Supply organization. Provides technical expertise and support to Manufacturing Operations to improve capacity, quality, cost or to establish root cause.
Duties and Responsibilities
• Lead/manage strategic projects (such as the Bulk Technology Transfer of a product from Development) from project initiation to closure including after action reviews.
• Advocate best practice project methodologies and tools. Develops, 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.
• Degree in Engineering, Pharmacy or Natural Science. At least 10 years’ experience in Pharmaceutical/Biotechnology development or production.
• Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework
• Good knowledge of various types 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.