At Elanco (NYCE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
The Scientist TSMS (Technical Services Manufacturing Science) is the steward of projects related to process improvement, process troubleshooting, 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:
Identify and prioritize strategies to reduce/mitigate negative impact on Site’s key success factors.
Performs troubleshooting 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 other TS/MS-Scientists in corrections needed in the processes to maintain them in a capable state.
Independently and collaboratively lead and execute experiments that identify the real root cause.
Suggest changes/improvements to update or improve existing Standard Operating 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 functions.
Create written documents such but not limited to 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).
Ability to work in a team environment.
Ability to maintain a flexible schedule.
Ability to manage projects within an agreed time schedule.
Basic Minimum Qualifications:
Bachelor’s degree in Engineering, Chemistry, Biology, Biochemistry, Veterinary Sciences, or other related field.
3+ years’ experience in the Biotech / Pharmaceutical industry.
Detailed understanding of biopharmaceutical production processes and technologies.
Working knowledge of cGMP standards and experience working in a regulated environment.
Proven analytical thinking and problem-solving skills.
Demonstrated success operating in cross-functional teams.
Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.
Strong verbal, written and interpersonal communication skills.
Strong organizational and computer skills.
Additional Preferences:
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.
Familiar with Microsoft Office software and SAP
Proficient in statistical analysis such as JMP
Other Information:
Location: Winslow, ME - Onsite (Please note this position has possibilities for relocation expenses for qualified candidates)
Shift: Position requires schedule flexibility including some nights and weekends.
Travel: May require some (10-25%) travel to assists other manufacturing sites.
Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable .
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
