Technical Lead Scientist – Advanced Therapies Manufacturing Full-time

Technical Lead – Technical Services/Manufacturing Scientist (TS/MS)

Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. 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. This is a unique opportunity to be a part of the team to help build a state-of-the-art facility and Technical System from the ground up, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

The Technical Lead – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical leadership and oversight to clinical and commercialization activities of gene therapy product 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.

Key Objectives/Deliverables:

• 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, as required, such as: tech transfer risk assessments / plans / reports, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, PFDs, etc.
• Manufacturing site representative for new product regulatory submissions, including authoring and/or reviewing relevant submission document sections.
• Collaborate with Commercialization Project Manager as well as 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, etc.

Basic Requirements:

• BS/MS in Biotechnology, Biochemistry or related quantitative field
• A minimum of 3 years of experience in pharma/biotech manufacturing industry
• Experience with new product submission and filing

Additional Preferences:

• Experience with product commercialization
• Demonstrated technical capability with high productivity
• Proven track record of curiosity with learning agility
• Self-starter with high initiative and data-driven approach to problem-solving
• Demonstrated strong interpersonal skills
• Demonstrated strong verbal and written communication skills
• Demonstrated adaptability and flexibility to working in different environments, teams etc.

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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 – $167,200. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.