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Associate Director - Analytical, QC, CMC Biologics

Employer
Eli Lilly and Company
Location
Remote, Indiana
Start date
Feb 9, 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.

Organization Overview:

The CMC team has an exciting opportunity for an innovative individual to join our organization and develop the growing oncology portfolio of small molecules and therapeutic proteins of various modalities (mAbs, bispecifics, antibody-drug conjugates, etc.).

The Associate Director, Analytical, QC will lead and support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple early-stage programs.

Responsibilities:

  • Work in a team environment to drive and manage analytical development activities primarily at third-party vendors including analytical method implementation, qualification/validation, and transfer for assigned drug substance and drug product projects.

  • Develop release/stability and characterization for assigned products/projects.

  • Manage product characterization and analytical comparability assessment activities.

  • Author and review analytical documents including but not limited to protocols, reports and procedures.

  • Write and review analytical sections in regulatory submission documents (e.g., IND, IMPD, BLA)

  • Manage, review, and analyze stability programs for assigned product/projects.

  • Serve as a technical expert and aid in analytical investigations and assay trouble shooting.

  • Key member of the interdisciplinary CMC project teams.

Basic Requirements:

  • BS degree required in chemistry, biochemistry or related scientific discipline.

  • Minimum of ten (10) years of experience working in a Biotech or Pharmaceutical FDA regulated industry or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.

Additional Preferences:

  • Experience with characterization of both large and/or small molecules.

  • Experience in analytical method development and qualification/validation for GMP testing.

  • Direct experience with managing outsourcing of assay development, stability, and quality control in support of CMC activities.

  • Experience managing and conducting stability programs, including real time, accelerated/forced degradation, and freeze thaw studies.

  • Proficient in data analysis and statistical methods for quality control processes.

  • Experience writing and presenting clearly on CMC topics.

  • Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions.

  • Demonstrable ability to work proactively, independently, and tenaciously.

Lilly (Eli Lilly and Company) currently anticipates that the base salary for this position could range from between $111,000-162,800 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, Loxo@Lilly (Eli Lilly and Company)  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, Loxo@Lilly (Eli Lilly and Company) reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Loxo@Lilly (Eli Lilly and Company) compensation practices and guidelines will apply regarding the details of any promotion or transfer of Loxo@Lilly (Eli Lilly and Company) 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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