Scientist - Downstream Process Development

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 35,000 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Reporting into the Process Development Group, the scientist will play a critical role in our efforts to advance the development of AAV gene therapy pipeline drugs for neurodegenerative disorders. They will develop, optimize, and characterize purification schemes for viral vectors, including technology transfer to GMP manufacturing. We are looking for an enthusiastic, self-motivated, hands-on candidate with excellent interpersonal skills who is comfortable working in an open environment spanning multiple functions.

While much of the day-to-day operations require wet-lab work, our team focuses not only on building everyone’s technical expertise but also fostering an environment for career growth as scientists in the biopharmaceutical industry. As process development relates to analytical development, quality, discovery and preclinical R&D, manufacturing, and regulatory functions, there is opportunity for exposure to the whole scope of biopharmaceutical industry processes.

Responsibilities:

• Lead, design, and perform downstream process development studies, including resin and buffer screens, process characterization, and scale up for novel viral vectors

• Author and review documents including development reports, SOPs, tech transfer protocols/reports, CMC sections of regulatory filings

• Lead technical interactions for the downstream process development, process validation, and technical supports for GMP Manufacturing

• Maintain a robust communication and presentation to all relevant internal functional groups and external partners.

• Build process understanding to support technology transfer to internal or external groups for manufacturing at pilot, engineering, clinical, or commercial scales

• Support internal viral vector material generation

• Participate in the expansion of internal process development capabilities

• Utilize electronic lab notebook and management systems (ELN/LIMS) to document and manage experimental data, protocols, reports, equipment status, and inventory

• Mentor/manage junior team members

Basic Requirements: 

• MSc with 1+ years, or BSc with 3+ years of relevant experience in a scientific discipline such as bioengineering, chemical engineering, biochemistry, or related field

Additional Requirements:

• Experience with designing and implementing IEX chromatography process development required.

• Experience with affinity chromatography and TFF preferred.

• Experience with AAV gene therapy process development preferred.

• Experience in process technical transfer preferred.

• Experience with regulatory filling, and quality assurance and quality control systems preferred.

• Experience in timeline management and resource planning preferred.

• Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well in a team

• Creative thinking, high level of ownership, multitasking in a fast-paced work environment.

• Position Location: NYC, Prevail Therapeutics a wholly owned subsidiary of Eli Lilly.
• Lilly currently anticipates that the base salary for this position could range from between $61,500 to $160,600 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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