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Scientific Director - Bioproduct R&D Upstream Process Development

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Feb 2, 2024

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Job Details

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.

The Bioprocess Research and Development team has an exciting opportunity for an innovative scientist, technical expert to join our process development organization. You will be part of a diverse team of biochemists, biologists, chemical engineers, and analytical chemists to develop Lilly’s growing portfolio of therapeutic products and various modalities (mAb, fusion proteins, bispecifics, multi-specifics, bioconjugates, ADCs, mRNA, AAV products, and etc.) at all stages of development.
 

Position Brand Description:

The Director/Sr Director/Executive Director of Upstream Process Development will oversee the development of drug substance upstream processes for biologics within Lilly’s biologics and emerging modalities portfolio. The primary responsibility will involve guiding a team of scientists and engineers to develop innovative solutions to enhance manufacturing processes for biologics pipeline and clinical phase programs. Drawing upon the extensive expertise in cell culture bioprocess development, the successful candidate will deliver innovative approaches, drive the progression of platform processes and play a pivotal role in advancing our portfolio. Moreover, we seek a candidate deeply dedicated to fostering employee growth and who thrives within a collaborative, intellectually stimulating, and fast-paced work milieu.

Responsibilities:

  • Lead and manage a proficient team of scientists and engineers accountable for upstream process development endeavors. These encompass various activities such as process design, optimization, characterization, scale-up, scale-down modeling, technology transfer, and addressing process troubleshooting. The focus will be on supporting a diverse biologics portfolio, including novel modalities, across early- and late-stage clinical development.
    • Advance upstream platform process technical strategy and capabilities for different modalities; drive and define creative process improvement initiatives, lead a team to deliver innovations that advance technical capabilities, improve process yield, robustness, scalability for biologics production.
  • Drive the progression of the upstream platform process technical agendas and enhance capabilities for diverse modalities. Spearhead process innovation initiatives, overseeing a team tasked with delivering innovations that elevate technical capacities, enhance process yield, robustness, and scalability for biologics production.
  • Act as an upstream development subject matter expert, providing pivotal technical guidance for process development, characterization, and commercialization initiatives. This oversight ensures a seamless path towards successful regulatory submissions for our portfolio. 
  • Author and review CMC documentation including CMC sections of regulatory submissions, technical reports crucial for filing and responding to questions from regulatory submissions.
  • Cultivate robust cross-functional collaborations within Development organizations and establish effective partnerships with Discovery, Manufacturing, and external entities, that are vital for product development and integration of new technologies.
  • Provide supervision, coaching, and mentorship to junior scientists and engineers, fostering their growth and development within the team.

Basic Qualifications

  • PhD in Chemical Engineering, Biotechnology/ Biological Engineering, Biology, Chemistry/Biochemistry, or related field.
  • 8+ years of industry experience in mammalian cell culture process development is a must have. Demonstrated competency, experience, and knowledge in biologics CMC development and compliance requirements from early to late clinical phase programs.
     

Additional Skills/Preferences:

  • Subject matter expertise in upstream process development, including extensive hands-on experience with cell culture process development.
  • Expertise with variety of cell culture processing platforms and production systems (mammalian, insect, bacterial).
  • Direct experiences in supporting regulatory submissions (INDs/BLAs) for various types of therapeutics especially new modalities is highly desired.
  • Proven ability to work cross functionally, effectively plan and organize work activities and prioritize to meet schedules and deadlines.

Additional Information:

  • Location: Indianapolis, IN
  • Travel: Up to 5%

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.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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