Bioprocess Scientist (Drug Product) – Advanced Therapies Manufacturing Full-time

Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist (TS/MS)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

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.

This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Position Description:

The Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing 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, media & buffer 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 (e.g., tech transfer, process validation, investigation, media & buffer recipe, formulation, 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 are addressed and resolved
• Ownership and technical stewardship of media and buffer preparation formulations
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, 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:

• BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry or related quantitative field
• 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, Engineering, or Quality Assurance.
• 3+ years experience with parenteral drug product manufacturing, particularly with formulation, technical transfer, visual inspection, statistical data trending and analysis and process risk assessment (e.g. FMEA).

Additional Preferences:

• In depth knowledge of gene therapy drug product manufacturing
• Experience with AAV drug product formulation, media and buffer preparation will be a plus
• 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
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems
• Demonstrated successful membership/leadership of cross-functional teams

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 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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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