Manufacturing Scientist

Role Summary

Manufacturing Scientist. Location: 450 Elanco Circle, Indianapolis, IN 46221 / Global Elanco Headquarters. Travel: 15-25% domestic travel for accompany validations, tech-transfers of manufacturing process, deviation investigations, and external site meetings.

The Manufacturing Scientist provides technical oversight of products within Elanco External Manufacturing (EEM) – Americas. They ensure technical excellence and effective supply across a portfolio of products (specifically medicated feed and nutritional health) produced at external contract manufacturers and suppliers.

Responsibilities

• Ensure technical oversight of products within Elanco External Manufacturing (EEM)–Americas (North and Latin America) scope.
• Ensure technical excellence and effective supply production across a portfolio of products (specifically medicated feed and nutritional health) produced at external contract manufacturers and suppliers.
• Maintain and improve product process capability, quality, and compliance as well as drive gross margin improvement through a technical productivity agenda are all part of this role.
• Participate in Joint Process Team (JPT) meetings with contract manufacturers and external suppliers as primary technical manufacturing science point of contact.
• Ensure technical requirements of global standards and oversight are met using Change Management, Deviation, and Investigation Management.
• Maintain oversight of key batch processing records used at CMs, including SOP’s, Master Production Records, Standard Packaging Instruction’s.
• Write technical reports to convey status of product performance, capability and to communicate process metrics.
• Act as the technical point of contact and subject matter expert for lifecycle aspects for Elanco External Manufacturing (EEM) managed products.

Qualifications

• Relevant experience – 5 years of progressively responsible post-baccalaureate experience in job offered or any engineering related job titles. Applicants must possess 5 years of experience in the following: (1) Scientific data collection and documentation (JMP’s – statistical tool); (2) Root Cause Analysis including defining problem statement, data collection and analysis, 5 whys, fish bone diagrams, identifying causal factors & root causes, and DMAIC (Define/measure/Analyze, improve and control) protocol; (3) cGMP and FDA regulations; (4) systematic troubleshooting for manufacturing issues including using statistical tools to define the operating parameters for a manufacturing process and analytical test; (5) analyzing manufacturing process failures; troubleshooting stability failures and raw materials issues (i.e. particle size change); (6) solid dosage processes; and (7) technical writing.
• 15-25% domestic travel required for accompany validations, tech-transfers of manufacturing process, deviation investigations, and external site meetings.

Education

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Chemistry and Pharmaceutical Science, a related field, or a foreign equivalent.

Skills

• Statistical data collection and documentation using JMP (and similar tools).
• Root Cause Analysis including problem statements, data collection/analysis, 5 Whys, fishbone diagrams, identifying causal factors and root causes, and DMAIC.
• cGMP and FDA regulations; systematic troubleshooting for manufacturing issues and defining operating parameters for processes and analytical tests.
• Manufacturing process analysis for solid dosage forms; troubleshooting stability and raw materials issues.
• Technical writing and reporting.