Contractor Scientific Associate Director (m/w/d)
• Lead/manage strategic projects (such as the Technology Transfer of a drug product from Development) from project initiation to closure including after action reviews.
• Advocate best practice project methodologies and tools. Develop, write and review project documentation including project plans, test protocols, risk assessments and reports.
• In collaboration with other MS&T functions 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 appropriate team lead.
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.
• Responsible for expanding and continuously updating a scientific knowledge base. Advises on Scientific and Business developments (including Technology, Processes, Regulations etc).
• Applies and advocates the use of QbD, Lean and 6 Sigma methodologies.
• Assist 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.
• Degree in Engineering, Pharmacy or Natural Science. At least 15 years’ experience in Drug Product Pharmaceutical/Biotechnology development or production. OSD is highly appreacited.
• Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework
• Good knowledge of various types of pharmaceutical drug product 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.