Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.
Responsible for formulation of vaccine products and 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 goals.
Functions, Duties, Tasks:
- Work cross-functionally to prepare formulation recipes from existing inventory for production of vaccines
- 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
- Monitors, optimizes, scale-up and improves existing manufacturing processes and ensures the processes remain in a capable state.
- Performs trouble shooting and Root Cause Analysis to prevent the recurrence of process deviations
- Independently and collaboratively lead and execute experiments that route to identify the real root cause
- Collaborate on or lead the assessment of process deviations
- Create new, 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
- Create documents to justify changes in the outline of production as needed
- 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)
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor’s degree in Engineering, Chemistry, Biology, Biochemistry, Veterinary Sciences, or other related field
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable
- 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 and SAP
- 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 processes, e.g. Tissue Culture, Fermentation, Chicken Embryo Origin Processes, etc.
- Ability to work in a team environment
- Ability to manage projects within an agreed time schedules
- 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