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Position Title: Senior Scientist TS/MS
Stewardship of projects related to process improvement, process trouble shooting, and process capability/control. Position requires strong interpersonal and collaborative skills and effectively work at different levels and functions at the organization. Collaboration in the setup of yearly objectives to accomplish the department and company goal. Responsible to run, coordinate and maintain all the activities related to the TSMS laboratory and its extended activities.
Functions, Duties, Tasks:
- Identify and prioritize strategies to reduce/mitigate negative impact on Site’s key success factors
- Performs trouble shooting and Root Cause Analysis in Critical Process Deviations to prevent its recurrence, independently or in collaboration with multifunctional teams.
- Provide liaison and support to local and network Quality Control (QC) and Analytical Science and Technology (AS&T) for assay performance troubleshooting and improvement
- Provides liaison and support to Elanco R&D for development and technical transfer of newly developed vaccines to site or existing vaccines site-to-site
- Supports Elanco Manufacturability Review process for veterinary vaccines
- Develop short- and long-term strategies to improve existing manufacturing processes and collaborate with TSMS-Scientists in corrections needed in the processes to maintain them in a capable state.
- Independently and collaboratively lead and execute experiments that route to identify the real root cause
- Suggest changes/improvements to update or improve existing Standard Operation Procedures (SOP’s) and manufacturing batch records as it is needed
- Perform and suggest changes to the processes maintaining the compliance with the current Quality Management System (Change Control Process) and Regulatory Regulations
- Identify critical parameters in the production processes, analyze trends and perform statistical analysis to support changes and propose solutions
- Perform process capability analysis
- Collaborate with Regulatory Affairs in the justification of changes in Special Outlines and Outlines of Production as needed
- Coordinate all the activities required for the manufacture of Production Seeds in collaboration with the Quality Control and Operations Fuctions.
- Create written documents such but not limited scientific protocols, final reports, engineering runs and plant trials
- Train operators, laboratory technicians, supervisors, etc., when new process, equipment or methodologies are implemented in the required functional area (s)
- Bachelor’s degree in Engineering, Chemistry, Biology, Biochemistry, Veterinary Sciences, or other related field
- Ability to work in a team environment
- Ability to maintain a flexible schedule
- Ability to manage projects within an agreed time schedules
- Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Familiar with Microsoft Office software
- Proficient in statistical analysis
- Possesses working knowledge in downstream processing for vaccine production, e.g. Lyophilization, Tangential Flow Filtration, Centrifugation, Emulsification, Filling, etc.
- Possesses working knowledge in vaccine antigen production and downstream processes, e.g. Tissue Culture, Fermentation, Chicken Embryo Origin Processes, etc.
- Position requires schedule flexibility including some nights and weekends. May require some (10-25%) travel to assists other manufacturing sites
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