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Senior Manager/Principal Scientist, CMC Regulatory Affairs

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Oct 31, 2023

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Discipline
Regulatory, Science/R&D, Biotechnology, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

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 CMC Regulatory Affairs Senior Manager/Principal Scientist will be responsible for participating in global CMC regulatory activities for Akouos’s gene therapy programs, from preclinical through to, and eventually beyond, market applications in line with US, European, and other applicable regulations.

Akouos, Inc., a wholly owned subsidiary of Eli Lilly and Company, is a leading precision genetic medicine company focused on inner ear disorders. We are developing targeted adeno-associated viral (AAV) vector-based gene therapies for sensorineural hearing loss, the most common form of hearing loss and one of the most common of all sensory disorders. The Senior Manager will create and guide CMC regulatory strategy in all stages of development with a strong focus on analytical, manufacturing, and facilities compliance. This person ensures timely preparation, review, and submission of documentation to regulatory authorities, maintaining compliance with applicable requirements. 

Duties and Responsibilities:
  • Participate in the development and execution of Regulatory CMC strategies for Akouos’s gene therapy programs.
  • Participate in the generation of CMC-related regulatory documentation and submissions in compliance with applicable regulations
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • Participate in regulatory agency interactions and meetings
  • Participate on cross-functional teams and provide Regulatory CMC guidance
Basic Qualifications:
  • Bachelors Degree and/or Masters Degree in life science field or related scientific discipline. Advanced degree preferred but not required.
  • 3+ years of experience with Regulatory CMC or related experience.

Additional Skills/Preferences:
  • Experience directly contributing to regulatory submissions with a focus on CMC aspects preferred; experience with viral vector gene therapy products preferred
  • Prior successful filing IND/CTA and/or BLA/NDA/MAA within timelines is preferred
  • Experience using electronic environments and eCTD for submissions/documentation management preferred
  • Working knowledge of FDA, EMA, and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to regulatory submissions
  • Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, and quality

Additional Information:
  • Lilly currently anticipates that the base salary for this position could range from between $109,500 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.

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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