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Hybrid Associate Vice President, AAV Drug Substance Process Development

Lilly · US, Indianapolis IN, Stati Uniti d'America · Hybrid

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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 Bioproduct Research and Development (BRD) organization strives to deliver innovative medicines to patients through the development and commercialization of monoclonal antibodies, novel therapeutic proteins, peptides, bioconjugates, cell therapies, gene therapies, and other genetic medicines etc. This organization is a multidisciplinary group that works collaboratively with our discovery, manufacturing and quality, business units. Located in Indianapolis and Boston, scientists have full access to our scientific excellence and engineering capabilities.

We are seeking an experienced and visionary Associate Vice President (AVP) of AAV Drug Substance Process Development. The successful candidate will be responsible for leading the design, optimization, and implementation of scalable and cost-effective AAV manufacturing processes. This role will play a critical part in advancing our gene therapy pipeline by fostering innovation, enhancing production efficiency, and ensuring the highest quality standards.

Key responsibilities

  • Develop strategic direction for the technology roadmap to shape the future of AAV manufacturing processes.
  • Establish and drive innovation initiatives to enhance process performance and reduce manufacturing costs for AAV.
  • Collaborate with the Analytical team to develop fit-for-purpose methods to shorten process development timelines as well as advanced PAT tools to be integrated into the manufacturing process.
  • Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Operations, to streamline innovation processes and accelerate the development and implementation of new technologies.
  • Ensure that the organization keeps current with latest scientific advancement and regulatory initiatives/requirements in bioprocess development and manufacturing field.
  • Provide scientific support and guidance to address and resolve technical challenges in portfolio projects.
  • Lead and drive the evaluation of external innovations and foster collaboration opportunities.
  • Contribute to a broad spectrum of technology advancement activities in BRD for multiple modalities.

Basic Qualifications

  • PhD in life Sciences, engineering or related fields, with a minimum of 15 years’ experience in pharmaceutical or biotech industry
  • In-depth and up-to-date experience in developing innovative technologies for the AAV manufacturing process.
  • Experience with mentoring and coaching senior level scientists and engineers.

Additional Skills/Preferences:

  • Extensive knowledge of the current bottlenecks in AAV manufacturing processes, with a proven history of driving innovation in this field.
  • Strong expertise in the CMC process development workflow, with a demonstrated ability to push the boundaries of innovation.
  • Experienced with regulatory requirements, including IND and BLA submissions.
  • Familiar with GMP operations and requirement with substantial experience in tech transfer to manufacturing.
  • Excellent communication, interpersonal, and leadership skills.
  • Demonstrated capability to work effectively with business partners and/or customers and to navigate through complex technical issues.

Location:

  • Indianapolis, Indiana
  • 10% business travel time

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$205,500 - $301,400

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).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.

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