Advisor - Technical Lead Scientist - Advanced Therapies Manufacturing

Eli Lilly and Company • Lebanon, IN

2d • Onsite

About The Position

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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. 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.

Requirements

• 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

Nice To Haves

• Experience with product commercialization
• Demonstrated experience managing and collaborating with CMOs
• 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.
• Demonstrated ability to participate in and facilitate decision-making

Responsibilities

• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior