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Lilly Director Bioproduct Analytical Development in Indianapolis, Indiana

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.

At Lilly, we serve an outstanding purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to build new medicines that will help solve our world’s greatest health challenges.

Bioproduct Research & Development has an exciting opportunity for an experienced analytical scientist to join our bioproduct analytical development organization! You will be part of a diverse team of analytical chemists, pharmaceutical scientists, cell culture and purifications engineers to develop Lilly’s growing portfolio of therapeutics of various modalities (proteins, peptides, oligonucleotides, gene and cell therapies, etc.) at all stages of development.

Responsibilities:

  • Lead analytical method and control strategy development for medium- and large-molecule projects, including oligonucleotides and other forms of gene therapy, therapeutic recombinant proteins, synthetic/pegylated peptide/proteins, and/or monoclonal antibodies.

  • Identify and monitor disruptive analytical technologies and trends; evaluate and/or implement new analytical capabilities/technologies to advance Lilly's current analytical capabilities for bioproduct testing; provide internal/external influence.

  • Support the definition of critical quality attributes and establish robust analytical control strategies that can be transferred into manufacturing and successfully registered globally.

  • Work with multidisciplinary teams and collaborate with other areas in process and product development, discovery, manufacturing, as well as outsourcing partners and other external parties. Deliver analytical solutions that enable process, product and analytical control strategy development.

  • Understand external regulatory requirements (USP, ICH, EMA etc.). Enable successful global regulatory approval for new products (both clinical and commercial).

  • May supervise other B.S./M.S./Ph.D. analytical scientists supporting bioproduct analytical development.

  • Lead research efforts through academic collaborations, internal postdocs, academic contractors, etc.

Basic Requirements:

  • Ph.D. in Analytical Chemistry, or a related field, with 10+ years of relevant experience.

  • AAV experience required.

Additional Skills/Preferences:

  • Expertise in cell and gene therapy product development.

  • Expertise in separation-based analytical techniques such as chromatography (SEC, IEX, HILIC, RP, etc.) and capillary electrophoresis (CE-SDS, icIEF), or other techniques (mass spectrometry, spectroscopy, PCR etc.) for the analysis of proteins, peptides, RNA/DNA, or AAVs.

  • Strong technical background in analytical chemistry. Proven record of excellent technical problem solving and innovative research experience.

  • High learning agility by identifying and exploiting new scientific concepts. Self-directed and highly motivated to achieve quality results in a fast-paced environment as well as pursue research and publication goals.

  • Strong written and verbal communication skills regarding both technical and business-related implications of your work.

  • Excellent interpersonal skills to work in a collaborative, cross-functional, team-oriented environment.

  • Ability to balance multiple activities, prioritize and handle ambiguity.

Additional Information:

  • Occasional travel

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 ( LillyRecruitingCompliance@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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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