At Elanco (NYSE: 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! Your Role: Technical Development Scientist - Operational Excellence As the Technical Development Scientist - Operational Excellence, you will play a pivotal role in advancing procedural enhancements and operational efficiency within the Vaccine Technical Development group. In this role, you'll collaborate with various functions, including Process Development and Analytical Development, to drive continuous improvement initiatives.
Your Responsibilities: Lead the inception, development, and management of procedural enhancements within the Vaccine Technical Development group.
Draft and oversee the routing of Standard Operating Procedures (SOPs), ensuring alignment with quality standards and regulatory requirements.
Supervise the progress of technical documents for regulatory submissions, ensuring timely completion.
Conduct quality control (QC) reviews of data packages and final reports.
Serve as the primary point of contact for documentation and processes associated with lab investigations, CAPAs, and audit observations.
What You Need to Succeed (minimum qualifications): Education: Bachelor's degree in Biology or related field with 5-8 years of industry experience.
Required Experience: A minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with a focus on technical development operations.
Top 2 skills: Strong leadership abilities and excellent communication skills.
What will give you a competitive edge (preferred qualifications): Experience with Veeva quality system or equivalent.
Knowledge of USDA licensure process and regulations.
Experience with quality standards (e.g., GMP) and regulatory agencies (FDA, USDA, EMA).
Previous lab experience
Additional Information: Travel: Domestic & International Travel may be required (10%)
Location: Fort Dodge, IA
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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
