Position Description: Provides front-line support to commercial vaccine manufacturing operations, as well as delivering process improvement and tech transfer projects, in compliance with cGMP and applicable regulatory guidelines and standards.

Functions, Duties, Tasks:

• Work with manufacturing and quality teams in execution of technical protocols, development activities, and technical transfer programs.
• Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
• Develop / execute projects to address process issues and deliver on improvement opportunities.
• Participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
• Provide support in resolution of technical and compliance issues, technical answers to QA, internal inspection bodies, and to Health Authorities.
• Author and assist in preparation and critical review of technical documents, APRs/PQRs, PFDs, batch records, SOPs, protocols, and reports.
• Demonstrate strict adherence to cGMP standards and Elanco policies and procedures. Maintain “safety first and quality always” mindset.
• Other duties as required.

Minimum Qualifications (education, experience and/or training, required certifications):

• A Bachelor of Science degree in Engineering, Chemistry, Microbiology, or equivalent is required. A Master’s degree in Engineering, Bio/Pharmaceutical Technology, Chemistry, Microbiology, or equivalent scientific degree is preferred.
• Minimum 1-3 years’ experience in the pharma/biotech industry, with emphasis on downstream purification processes is preferred.
• Knowledge in molecular biology and nucleic acid platform technologies.
• Good understanding of biopharmaceutical production processes.
• Experience with operations in a commercial cGMP manufacturing facility would be beneficial.
• ability to lead multi-disciplinary project teams with excellent communication, problem-solving, and critical-thinking skills.

Other:

• Must have the flexibility/ability to work evenings and weekends if the business requires it.
• Must have the flexibility/ability to work overtime if the business requires it.

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