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Search our job listings below. Organization A member of the Technical Services / Manufacturing Science (TS / MS) group, with responsibility for Elanco Contract Manufacturing Operations.
Reports to the EEM-EMEA Technical Services / Manufacturing Science (TS / MS) Director. The holder will work normal office hours but will be required to travel to contract manufacturers across Europe.
Normal travel time typically will not exceed 20% of the time. Provides ongoing technical oversight for EEM-EMEA Contract Manufacturers as part of the Joint Process Team (JPT) structure with the goal of maintaining product supply by managing process deviations and change controls, optimizing and improving product quality, product yield, process control and throughput, whilst ensuring that the validated state is maintained. Responsibilities :
Develop deep technical understanding of the manufacturing process(es), including an awareness of good manufacturing practices, and industry best practices.
Establish a strong business relationship with key contacts at CM organization(s) to enable remote technical stewardship of processes, and to ensure effective lines of communication are in place.
Analyze manufacturing process data on an ongoing basis, to monitor performance with respect to quality, potency and yield using appropriate statistical methods and control charts.
Support the investigation of deviation investigations an CMOs. Trend stability data as required.
Take ownership for key TS / MS documents, including the process flow document, Internal Alert Limit Assessments, Distribution Temperature Profiles etc.
Use data and process knowledge to identify continuous improvement (CI) opportunities.
Participate in annual product review (APR) process, taking ownership for TSMS deliverables, including assessment of ongoing suitability of TS / MS documents.
Update key documents as required. Use data and process knowledge to identify continuous improvement (CI) opportunities. .
Liaise with key personnel at the CM, and internal functions (e.g.QA, supply chain and regulatory functions) to deal with day-to-day issues, including, deviation resolution, change management and complaints.
Provide technical oversight and leadership, as required, in the implementation of projects, including capital projects, with respect to planning, documentation, commissioning & qualification, training and process / cleaning validation.
Ensure appropriate governance is in place for technical changes, through use of the current change management processes.
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 joint process team meetings; ensure TS / MS requirements of global contract manufacturing standards are met.
Provide TS / MS support as well as leadership for technical transfers as required. Requirements :
Minimum qualifications / certification required for this job ( if applicable )
Minimum of BSc (or equivalent) in relevant discipline, and appropriate experience within pharmaceutical industry. Elanco is an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status