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Lead Bioprocess Scientist for Gene Therapy

2 months ago

Lebanon, Indiana, United States Eli Lilly Full time

Company Overview:

At Eli Lilly, we combine compassion with innovation to enhance the quality of life for individuals globally. As a prominent player in the healthcare sector, our headquarters is situated in Indianapolis, Indiana. Our global workforce is dedicated to discovering and delivering transformative medicines, enhancing disease understanding and management, and contributing to our communities through charitable initiatives and volunteer efforts. We prioritize our work and place people at the forefront of our mission.

Facility Development:

Eli Lilly is in the process of establishing a state-of-the-art facility dedicated to the production of novel modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility will represent our most advanced manufacturing site, concentrating on the introduction of groundbreaking products. It will incorporate next-generation manufacturing technologies alongside sophisticated data collection and analysis systems aimed at enhancing safety, quality, and operational performance. This role presents a unique chance to contribute to the establishment of a greenfield manufacturing site, where the successful candidate will play a pivotal role in designing, commissioning, and initiating the facility for both clinical and commercial production.

Position Overview:

The Technical Services/Manufacturing Scientist (TS/MS) position for parenteral drug products is tasked with delivering technical expertise for the development, implementation, and execution of compliant manufacturing processes for gene therapy drug products. Initially, the focus will be on filling and packaging operations, as well as visual inspection processes, from the facility's startup phase through validation and commercial manufacturing support.

Key Responsibilities:

  1. Provide technical guidance for all startup activities related to parenteral drug product manufacturing, including filling, packaging, technology transfer, and process validation.
  2. Comprehend the scientific principles essential for the production of gene therapy drug products, encompassing the interplay of chemistry, equipment, aseptic techniques, and container closure systems.
  3. Ensure that comprehensive instruction sets and process flow diagrams accurately depict the manufacturing processes and control strategies.
  4. Prepare, review, and approve essential technical documentation, including change controls, regulatory submissions, deviation investigations, validation protocols, and summary reports.
  5. Engage in the development and implementation of process enhancements while collaborating positively within cross-functional teams to achieve TS/MS objectives and quality targets.
  6. Monitor and respond to established statistical metrics in real-time to evaluate process variability and capability.
  7. Utilize manufacturing process knowledge and data analysis skills to support daily operational management.
  8. Act as a technical liaison with external stakeholders.
  9. Provide inspection support as necessary.
  10. Maintain a safe working environment by adhering to safety regulations and actively participating in safety initiatives.

Basic Qualifications:

A Bachelor’s or Master’s degree in Engineering, Biochemical Engineering, Biochemistry, or a related quantitative discipline, along with a minimum of three years of experience in cGMP manufacturing, particularly in Operations, Validation, TS/MS, Engineering, or Quality Assurance.

Preferred Qualifications:

  • Extensive knowledge of gene therapy drug product manufacturing.
  • Experience with filling equipment and/or isolator technology.
  • Familiarity with serialization and packaging processes.
  • Experience in AAV drug product formulation, as well as media and buffer preparation.
  • Strong interpersonal and teamwork capabilities.
  • Excellent self-management and organizational skills.
  • Proficient oral and written communication skills, capable of conveying information clearly and succinctly to all organizational levels.
  • Experience in data trending and analysis.
  • Aptitude for analyzing complex data and resolving issues.
  • Demonstrated success in cross-functional team membership or leadership.