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.
This is an exciting opportunity to help build a state-of-the-art facility and Materials Management System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description:
The Sr. Scientist - Materials Management - Technical Services/Manufacturing (TS/MS) role will provide technical oversight of raw materials and consumables utilized during the manufacturing of gene therapy products to ensure the reliable supply of material with safety first and quality always. Scope of work includes qualification, implementation, continuous improvement, investigation support and technology transfer. This position will interact with Engineering, Operations, Quality Assurance, Quality Control, Procurement and Regulatory groups in Lebanon Advanced Therapies (LP2) site and globally as well as with external suppliers. Knowledge of cell culture, purification and the support systems used in the manufacture of biotech products is required.
Key Objectives/Deliverables
- Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products, especially as concerns the impact of material attributes on process chemistry & product protection.
- Serve as scientific liaison between the Materials Management Team and Process Scientists.
- Establish and own the site’s Extractables and Leachables (E&L) program to create documented risk assessments to enable manufacturing start.
- Work with the Materials Management Team to:
- Assess materials & supplier risk
- Audit suppliers
- Assess & address impact of supplier changes (drawing input from affected flow(s) scientific SMEs)
- Develop robust control strategies to manage supplier/material risk.
- Prepare, review, approve and provide technical support for preparation of relevant technical documents such as change controls, deviation investigations, plant trial protocols and summary reports, procedures, technical reports, etc.
- Lead and/or coordinate materials investigations and changes.
- Collaborate with site and global resources to support materials related laboratory studies.
- Own (or provide input to) materials components of Annual Product Reviews, Management System Reviews, etc.
- Work with manufacturing Process Team counterparts to assess/investigate materials issues and implement materials changes.
Basic Requirements:
- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field
- 3+ years of experience in cGMP manufacturing, specifically within TS/MS, Validation, Operations, or Engineering
- Experience in liaising with material and consumable suppliers
Additional Preferences:
- M.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field preferred but not required
- Knowledge of cell culture, purification and the support systems used in the manufacture of biotech products
- Demonstrated technical capability with high productivity
- Proven track record of curiosity with learning agility
- Self-starter with high initiative and data-driven approach to problem-solving
- Demonstrated strong interpersonal skills
- Demonstrated strong verbal and written communication skills
- Demonstrated adaptability and flexibility to working in different environments, teams etc.
- Demonstrated ability to participate in and facilitate decision-making
- Experience in external manufacturing
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
$66,000 - $171,600
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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