Bioprocess Scientist (Drug Product) - Advanced Therapies Manufacturing
About The Position
Lilly is a global healthcare leader committed to uniting caring with discovery to make life better for people worldwide. We are seeking a Bioprocess Scientist for our cutting-edge manufacturing facility in Lebanon, Indiana, dedicated to genetic medicines. This facility is Lilly’s most technically advanced, focusing on next-generation manufacturing technologies and advanced data analytics. This is a unique opportunity to be part of the startup of a greenfield manufacturing site, contributing to the design, commissioning, and startup for both clinical and commercial supply. The Technical Services/Manufacturing Scientist (TS/MS) role will provide technical support for the development, implementation, and execution of compliant manufacturing of gene therapy drug product. The initial focus will be on formulation, media & buffer preparation, Drug Product Filling & packaging, and visual inspection operations, from facility startup through validation and commercial manufacturing.
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).
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
