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:

This 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 equipment and/or isolator technology

• Experience with serialization and packaging

• Strong interpersonal and teamwork skills

• Strong self-management and organizational skills

• Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization

• Ability to analyze complex data and solve problems

• Demonstrated successful membership/leadership of cross-functional teams

• Experience with technical transfer, statistical data trending and analysis, and process risk assessment (e.g., FMEA) in a drug product context

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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