TS/MS Process Steward - Advanced Therapies Manufacturing

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.

Company Overview

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.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. 

Position Description

Process Steward – Technical Services/Manufacturing Scientist (TS/MS) role will provide technical ownership and successful execution of the Validation Program at the Lebanon Advanced Therapies (LP2) site. TS/MS Validation personnel provide stewardship of the site’s Validation Program, including assessment of and improvement in existing controls.

The TS/MS Process Steward works with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process.

Key Objectives/Deliverables

• Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization
• Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products
• Write validation protocols and reports in support of the site’s validation programs
• Provide support for other TS/MS related process activities as needed
• Investigate and troubleshoot problems which occur during manufacturing
• Plan and execute validation activities, including cross-functional coordination and internal coordination with Sterility Assurance Scientists
• Prepare and provide technical review of completed/executed validation packages by compiling and analyzing validation data for submission and approval
• Lead resolution of validation deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
• Maintain an up-to-date knowledge of validation requirements, practices, and procedures
• Write validation plans and risk assessments related to specific projects, facilities, products
• Write and review policies and procedures (SOPs)
• Perform risk assessments for validation programs
• Perform and/or coordinate validation studies, testing, verification, and sampling
• Provide technical input for control strategies for the introduction of new products (e.g. CTs), as it relates to Cleaning, Filter and Sterilization Validation
• Represent/defend validation strategies during internal assessments / audits and external regulatory inspections
• Maintenance and continuous improvement of the Validation programs
  
  
  

Basic Requirements

• Bachelors degree in Engineering, Biochemistry, Pharmacy or related field
• 3 years of experience in pharma/biotech manufacturing industry
• Experience with process and/or cleaning validation
  
  
  

Additional Preferences

• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Attention to detail, excellent review skills and analytical skills
• Understanding of cGMPs and applicable internal standards
• Ability to drive change and motivate others toward a common vision
• Must have strong ability to organize and manage multiple tasks in a fast-paced environment
• Experience in Operations, TS/MS, QA, QC, Regulatory, or Supply Chain within pharmaceutical manufacturing
• Hands-on experience supporting/executing qualifications related to various processes and activities
• Demonstrated understanding reviewing/writing technical documents, risk assessments/impact assessments, validation documents, protocols and final reports
  
  
  

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

$64,500 - $143,000

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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