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Sr. Director TS/MS

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Mar 26, 2024

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 Sr. Director - TS/MS provides technical leadership for the of API External Manufacturing (API EM) portfolio.  The Sr. Director TS/MS is responsible for interfacing with development scientists and teams to provide manufacturing guidance/feedback during the development phase and to facilitate technical transfers into commercial manufacturing and initial validations with API EM and CMs. The Sr. Director TS/MS is responsible for leading scientists involved in technical aspects of API manufacturing and developing a technical agenda based on sound scientific principles.  The Sr. Director manages the technical staff responsible for the development and delivery of programs for continuous process optimization and improvement. 

Responsibilities:

Key Objectives/Deliverables:

  • Serve as a technical resource to Manufacturing Scientists, Managers, SMDD, and other disciplines, departments, sites and networks.
  • Assure API EM manufacturing processes adhere to Lilly quality expectations and stay current with ICH GMP principles.
  • Provide technical support for non-routine (e.g., deviation, process change) investigations, including consultation on quality and stability issues. 
  • Review and approve relevant technical documents, such as: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
  • Manage TS/MS technical agenda and projects (experimental, modeling and/or production data analysis) to improve process control, quality, compliance, yield, and/or productivity. 
  • Provides expert oversight and guidance to small molecule laboratory.
  • Support identification and development of new manufacturing technologies into the TS/MS Laboratories and subsequent implementation for the improvement of existing commercial manufacturing processes.
  • Provide technical oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects.

Education Requirements:

Doctorate or equivalent experience in the scientific disciplines of Biochemistry, Organic Chemistry, Physical Chemistry, Analytical Chemistry, or Bio/Chemical Engineering.


Basic Requirements:
High-quality skills to include: scientific knowledge, data analysis, ability to prioritize, attention to details, written and oral communication, critical decision making, interpersonal/people, supervisory, computer applications, complex problem solving, mentoring/leadership; self-motivation, clear understanding of all cGMPs, policies, procedures, and guidelines, and ensuring a fair, equitable, and safe work environment.


Additional Skills/Preferences:
Additional relevant industrial experience in any of the following associated disciplines such as API Manufacturing, Quality Control, Quality Assurance, Process Engineering, Advanced Project Management, Regulatory, Development, or Administration is desirable.
Additional Information:

  • Must complete ITP for Sr Director TS/MS.
  • No certifications required.
  • Tasks require entering manufacturing areas which require wearing appropriate PPE.
  • Some travel may be required (10-25%)
  • Location US

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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