Bioprocess Scientist (Downstream) - Advanced Therapies Manufacturing

About the role

We are seeking a Downstream Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) to provide technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture at our new, cutting-edge manufacturing facility in Lebanon, Indiana. This greenfield site is Lilly’s most technically advanced, focused on next-generation manufacturing technologies and advanced data collection and analysis platforms. The successful candidate will help design, commission, and start up the facility for both clinical and commercial supply, building 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. This role requires deep technical expertise in the science behind the molecule and process, strong working skills on manufacturing equipment and control systems, and data-driven decision-making and problem-solving capabilities.

Responsibilities

• Develop in-depth knowledge of the science behind the molecule and processes, including the process control strategy for AAV and gene therapy products.
• Provide technical support for internal and external TS/MS activities, including tech transfer, process validation, investigations, process stewardship, and improvement.
• Understand the scientific principles required for manufacturing AAV drug substances and products, with extensive hands-on experience in chromatography operation, TFF, viral filtration, and sterile filtration.
• Own and provide technical stewardship of bioprocesses, including technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes.
• Work as part of cross-functional teams to bridge the gap between science/engineering and floor operations, bringing deep technical expertise to the team.
• Assess whether the process is in control, capable of meeting its stated purpose, and maintained in a validated state.
• Identify process improvements and participate in Lean manufacturing initiatives.
• Prepare, review, approve, and provide technical support for relevant technical documents, such as change controls, regulatory submissions, deviation investigations, validation protocols, processing records, process description documents, and annual reports.
• Support and/or lead TS/MS technical projects to ensure successful start-up, improve process control, yield, product quality, and/or productivity.
• Implement process changes and improvements through the technical agenda.
• Develop, monitor, and react to statistically based metrics in real-time to assess process variability and capability.
• Serve as a technical interface external to the Lebanon site.
• Provide audit support as needed.
• Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business and quality objectives.
• Ensure a safe working environment through compliance with safety rules and active participation in safety-related activities.

Requirements

• B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related quantitative field.
• 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering.

Preferred Qualifications

• In-depth knowledge of gene therapy manufacturing.
• Experience with large-scale AAV vector production using single-use bioreactor systems.
• Experience using solution filling equipment and/or isolator technology.
• Experience with QC assays in line with product CQAs, including variability.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.
• Strong oral and written communication skills, demonstrating the ability to communicate effectively 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.

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits.
• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $66,000 - $171,600. Full-time equivalent employees are also eligible for a company bonus, depending on company and individual performance.