Senior Scientist - TSMS

Organization Overview

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM TS/MS Sr. Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Sr. Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners team members and site management.

The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

Key Objectives/Deliverables

• Provide technical oversight and stewardship for peptide manufacturing processes.
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Employ excellent communication skills to manage internal and external relationships.
• Build and maintain relationships with development and central technical organizations.
• Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintaining peptide processes in a state of compliance with US and global regulations
• Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Operate with 'Team Lilly' in mind - including coaching and mentoring of peers and other scientists.

Basic Requirements

• Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred)
• 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Preferences

• Knowledge and experience with Regulatory requirements
• Knowledge of data management practices across manufacturing
• Enthusiasm for changes, team spirit and flexibility
• Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
• Proficiency in delivering complex tasks and/or tasks that are cross-functional
• Demonstrated Project Management skills and ability to coordinate complex projects

Additional Information

• Some travel (<25%) is required
• Some off-shift work (night/weekend) may be required to support 24/7 operations
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status).