Sr. Scientist – TS/MS – Dry EM

Job Type: Location Type: Not Specified

 

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 – $92,400

Responsibilities

The TSMS Representative role provides the technical support and leadership required to achieve the reliable and compliant manufacture of the Dry Products External Manufacturing (Dry-EM). The TSMS Representative works with the technical staff responsible for the development and delivery of programs for continuous process optimization and improvement for new and existing medicines introduce on Contract Manufactures, support technical transfer, and optimize existing control and capacity to maintain the reliable supply for products across the Dry-EM.

Key Objectives/Deliverables:

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Develop and steward operational control strategies.
• Serve as a technical leader and mentor for Scientists, Managers, and other disciplines.
• Maintain interface with the TS/MS function, development, regulatory, engineering, customers, and contract manufacturing organizations
• Manage TS/MS technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
• Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
• Review/approve relevant technical documents, such as: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
• Remain current with all the regulations (global GMP expectations, regulatory expectations, health, safety, and environmental regulations)
• Provide support to internal and joint process teams.
• Make regular communication with and visits to External Manufacturers to ensure current awareness of their operations and to maintain a strong working relationship with External Manufacturers, and the local affiliate if necessary.

Basic Qualifications

• Education:
  • Bachelor’s Degree or equivalent work experience in scientific disciplines of Biochemistry, Organic Chemistry, Physical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry or Engineering.
• Experience:
  • Demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
  • Relevant industrial experience in any of the following disciplines such as API Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Regulatory, Development, or Administration.
• Skills:
  • Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner
  • A thorough understanding of cGMPs and drug product manufacturing
  • Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment
  • Good communication skills, especially attention to detail in written procedures and protocol development
  • Capability to work in a virtual and complex environment
  • Willingness to travel
  • Appreciation for cultural diversity and inclusive leadership
  • Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools & principles

Additional Skills/ Preferences

• Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
• Ability to work independently as well as part of a team.
• Ability to prioritize activities.
• Good judgment and flexibility.
• Language: English

Additional Information

• Off hours may be necessary to support operations
• Travel is possible, up to 30 %

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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 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.

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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