Sr. Scientist Technical Services/Manufacturing Science API-EM
Eli Lilly and Company
Summary
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 (Technical Services / Manufacturing Science) Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment.
Job description
The 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 supporting ongoing manufacturing at our External Partners through tasks such as 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. This is a Biologics (Mabs, Recombinant Enzymes, ADC) position. 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.
Responsibilities
- Provide technical oversight for biologics manufacturing processes, leveraging a strong technical foundation and previous experience supporting these 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 biologic 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 the process and equipment.
- Operate with 'Team Lilly' in mind.
Additional Information
Some travel (<25%) is required. Some off-shift work (night/weekend) may be required to support 24/7 operations. This position is located onsite in Indianapolis, IN and is not approved for remote work. Relocation assistance will be provided.
Requirements
- Bachelors in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred)
- 3+ years of demonstrated hands on working experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations
- Qualified applicants must be authorized to work in the United States on a full-time basis
- Strong understanding of regulatory requirements and their application in a manufacturing environment
- Proficient in data management practices across manufacturing operations
- Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change
- Proven ability to effectively communicate and influence across diverse technical and business teams
- Skilled in managing and delivering complex, cross-functional initiatives
- Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Relocation assistance
- Company bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.