Drug Product Manufacturing Scientist - Advanced Therapies Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The

TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

** Position

Description:

*
* ** T*
* ** his is a Drug Product-focused role responsible for supporting  final formulation, parenteral manufacturing, and visual inspection of gene therapy products.
** The Drug Product Manufacturing Scientist - Technical Services/Manufacturing Scientist (TS/MS) will provide technical support for the development, implementation, and execution of compliant manufacturing of gene therapy drug product. The scope of the role will initially focus on  
** formulation, drug product buffer and excipient preparation, Drug Product Filling & packaging, and visual inspection operations** , from facility startup through support of validation processes and commercial manufacturing.

** Key Objectives/Deliverables:*
* + Provide technical support for internal and external TS/MS activities  
** specific to drug product operations**  (e.g., tech transfer, process validation, investigation, drug product formulation buffer/excipient recipe development, filling & packaging, and visual inspection)

+ Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems

+ Responsible for ensuring that formulation issues in the  
** final drug product
** are addressed and resolved

+ Ownership and technical stewardship of drug product formulation buffer and excipient preparation

+ Prepare, review, approve, and provide technical support for preparation of relevant technical documents, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents, and annual reports

+ Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda

+ Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability

+ Apply manufacturing process knowledge and data analysis skills to support the management of daily manufacturing operations

+ Serve as technical interface external to the Lebanon site

+ Provide audit support, as needed

+ Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives

+ Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

** Basic Requirements:*
* + B.S. in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry or related quantitative field

+ 3+ years of experience with parenteral or sterile drug product manufacturing, specifically in formulation, aseptic fill-finish, visual inspection, or packaging operations

+ 3+ years of experience in cGMP manufacturing within Operations, Validation, TS/MS, MSAT, Engineering, or Quality Assurance, with direct exposure to drug product unit operations

+ Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

** Additional Preferences:*
* + In-depth knowledge of gene therapy or cell therapy drug product manufacturing

+

Experience with AAV drug product formulation, media and buffer preparation

+ Experience using solution filling…