Advisor - Technical Lead Scientist - Advanced Therapies Manufacturing

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.

Lilly is currently constructing a cutting‑edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be our most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It will include next‑generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.

The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Technical Lead – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical leadership and oversight to clinical and commercialization activities of gene therapy products at the Lebanon Advanced Therapies (LP2) site. The scope of the role includes all clinical trial and commercialization gene therapy products such as technology transfer, validation, drug substances and products production, inspection, submission and filing.

The TS/MS Technical Lead can be involved with clinical trials and supports all commercialization activities up to submission and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and LP2 commercialization procedures. The TS/MS Technical Lead works with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process.

• Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization.
• Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products.
• Support identification and development of new manufacturing technologies and processes to support commercialization.
• Lead risk management activities as it pertains to new products (FMEA).
• Own Tech Transfer strategy for the manufacturing site.
• Ensure that an accurate instruction set (eBRs and procedures) and PFD describe the process and control strategy for new products.
• Drive technical excellence through meaningful specifications, including approval of local specifications and influencing global specifications.
• Understand, justify, and document the process validation strategy for new products.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, such as tech transfer risk assessments, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, and PFDs.
• Manufacturing site representative for new product regulatory submissions, including authoring and/or reviewing relevant submission document sections.
• Collaborate with Commercialization Project Manager and cross‑functional tech transfer team members to commercialize new products in LP2.
• Serve as technical interface with development.
• Communicate effectively with process team members, development colleagues, tech transfer team members, and other parties.
• Identify opportunities for best practices and implement improvements to manufacturing technology.
• Own and prepare Annual Product Reviews.

• B.S. in Biotechnology, Biochemistry or related quantitative field.
• 3+ years of experience in pharmaceutical/biotech manufacturing industry.
• 1+ year of experience with new product submission and filing.

• Experience with product commercialization.
• Demonstrated experience managing and collaborating with CMOs.
• Demonstrated technical capability…