Senior Specialist - API at Elanco in Elwood, Kansas

Job Description:

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Position Description:

Supervisor Role needed to assist and lead technicians in the aseptic filling and finish of sterile injectable pharmaceuticals. Role will schedule and manage day to day operations of department technicians and workloads and maintain overall department, company and regulatory requirements.

Basic Minimum Requirements:

• High School Diploma with a minimum of three years of manufacturing in a regulated industry.


• Strong leadership, team building, organizational and interpersonal skills. Strong analytical competency


•    Knowledge and understanding of biopharmaceutical and pharmaceutical operations 



•    Highly effective oral and written communication skills 



•    Self-starter, ability to work independently and with minimal direction 



•    Demonstrated ability to work collaboratively and across multiple departments and organization levels 



•    US FDA and EMA experience. Other National Competent Authority experiences a plus 



•    Ability to prioritize tasks, and ascertain what problems and issues should be escalated to Senior Management



•   Ability to think strategically, to communicate well, build relationships, and foster teamwork


•   Analytical Skills: Highly analytical and strong advocate for process improvement

Functions, Duties, Tasks:

• Perform and lead technicians in the aseptic filling and finish of sterile injectable pharmaceuticals


• Schedule and manage day to day operations of department technicians and workloads


• Operate and manage all aseptic formulation, filling, labeling, and packaging equipment


• Perform and train on all procedures according to SOP’s and manufacturing directions


• Provide direction and leadership in the area of fill and finish manufacturing


•   Work closely with Bioproduction, Process Development, and Quality to ensure product flows smoothly from drug substance hand off through finished goods


•   Promote a Quality culture within the fill and finish team and throughout the organization


• Maintain, review and train on written batch production records for fill and finish manufacturing, ensuring detailed, accurate, concurrent, and complete record keeping


• Maintain environment to meet all applicable USDA/FDA/EMA cGMP regulations within department


• Build and foster a strong and positive work environment for department and technicians

Additional Preferences:

• Bachelor of Science preferred with experience in a regulated manufacturing 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

Salary: