Advisor - Technical Lead Scientist - Advanced Therapies Manufacturing

The 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 includes technology transfer, process validation, drug substance and product production, inspection, submission, and filing for both clinical and commercial supply. Key Objectives / Deliverables Understand the scientific principles required for manufacturing intermediates, bulk drug substances, and drug products for gene therapy commercialization. Provide product and process technical knowledge to identify appropriate manufacturing approaches for new products. Support identification and development of new manufacturing technologies and processes. Lead risk management activities (e.g., FMEA) related to new products. Own the tech‑transfer strategy for the manufacturing site. Ensure accurate instruction sets (eBRs, procedures) and Process Flow Diagrams (PFDs) describe the process and control strategy. Drive technical excellence through specifications, including local approval and global influence. Define, document, and execute the process validation strategy. Prepare and review technical documents such as risk assessments, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, and PFDs. Represent the manufacturing site for new product regulatory submissions, authoring or reviewing relevant sections. Collaborate with the Commercialization Project Manager and cross‑functional tech‑transfer team. Serve as the technical interface with development. Communicate effectively with process teams, development colleagues, and other stakeholders. Identify best‑practice opportunities and implement technology improvements. Own and prepare Annual Product Reviews. Basic Requirements B.S. in Biotechnology, Biochemistry, or a related quantitative field. 3+ years of experience in the pharmaceutical or biotech manufacturing industry. 1+ year of experience with new product submission and filing. Additional Preferences Experience with product commercialization. Demonstrated experience managing and collaborating with CMOs. Demonstrated technical capability with high productivity. Proven track record of curiosity and learning agility. Self‑starter with high initiative and a data‑driven approach to problem solving. Strong interpersonal, verbal, and written communication skills. Adaptability and flexibility to work in diverse environments and teams. Ability to participate in and facilitate decision‑making. Compensation for this position ranges from $129,000 – $189,200 per year, depending on education, experience, and location. Full‑time employees are eligible for a performance‑based bonus and an extensive benefits program that includes 401(k) participation, pension, vacation, medical, dental, vision, prescription drug coverage, life insurance, flexible spending accounts, and well‑being benefits such as employee assistance and fitness programs. Lilly is dedicated to providing accommodations for individuals with disabilities. If you require an accommodation to submit a resume for a position, please use the accommodation request form at Lilly is an equal‑opportunity 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, veteran status, disability, or any other legally protected status. #J-18808-Ljbffr BioSpace, Inc.