Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees in more than 70 countries. Founded in 1954, Elanco is a division of Eli Lilly and Company.
Technical Services/Manufacturing Scientist - Specialising in Parenteral Manufacturing
Provide technical oversight in a cGMP environment for a range of pharmaceutical products manufactured at contract manufacturers across Europe, with the goal of maintaining, optimising and improving product quality, product yield, process control and throughput, whilst ensuring that the validated state is maintained.
Develop deep technical understanding of the manufacturing process, including an awareness of good manufacturing practices, and industry best practices
Establish a strong business relationship with key contacts at contract manufacturing (CM) organisation(s) to enable remote technical stewardship of processes, and to ensure effective lines of communication are in place
Analyse production data on an ongoing basis, to monitor performance with respect to quality, potency and yield using appropriate statistical methods and control charts. Investigate and complete deviation investigations, using root cause analysis and other relevant investigative techniques
Take ownership for key process governance documents, including the process flow document (PFD) and the process validation master plan (VMP). Participate in annual product review (APR) process, taking ownership for technical deliverables, including assessment of ongoing suitability of the PFD and VMP.Update key documents as required
Use data and process knowledge to identify continuous improvement (CI) opportunities. Design, execute and document trials, including lab work, to generate data to support CI proposals
Liaise with key personnel, at CM, and in QA, QCL, scheduling and regulatory functions to deal with day-to-day issues, including processing issues, deviations and complaints
Play a proactive role in the implementation of projects, including capital projects, with respect to planning, documentation, commissioning, training and process/cleaning validation. Ensure appropriate governance is in place for changes, through use of the current change management processes
Maintain oversight of key batch processing records used at CMs, including SOP’s, Master Production Records, SPI’s
Write technical reports to convey status of key initiatives, and to communicate process metrics
Participate in regular site visits to the CM, to assess ongoing capability and, as required, to support resolution of complex technical issues and/or support implementation of significant process or procedural changes
Participate in team meetings; ensure technical requirements of global standards are met
Provide technical support for technical transfers, including sourcing, transfer planning, transfer execution
Deep technical understanding of parenteral manufacturing, experience of parenteral process validations, process optimisation, deviation investigation, change management and annual product reviews.
Minimum of BSc in relevant discipline (or equivalent) and significant proven experience in the pharmaceutical industry, working in manufacturing (production/quality/engineering/technical).
Demonstrate troubleshooting skills.
Interpersonal and influencing skills.
Proven ability to understand and analyse process data.
Experience of the technical transfer or project management of production processes at manufacturing scale is desirable.
Excellent interpersonal skills with the ability to work as an individual or as part of a close working team with clear business objectives delivered as required.
Can author technical documents to a high standard and is current with cGMP requirements in aspects of process validation, process change design and process monitoring compliance.
Can apply excellent problem solving methodology to complex technical situations within required deadlines using statistical data analysis as a tool and means to identify improvements.
Confident in team environment to contribute and challenge the status quo and take a technical stand when required - can represent technical information to senior management in a clear and concise manner.
Can build relationship with direct team members as well as external partners such that collaboration and influence are key to being successful in this role.
Multi-tasking and priority management essential.
Flexibility in travel (sometimes at short notice) to support business deadlines and customer requirement.
Travel is likely to be restricted to Europe for short durations.
The holder will work normal office hours but will be required to travel to contract manufactures across Europe.