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 Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description:
The Bioprocess - Technical Services/Manufacturing Science (TS/MS) role provides technical support to ensure the reliable and compliant manufacture of gene therapy drug substance at external contract manufacturing groups and, when needed, at LP2, in accordance with global quality standards. This person interacts daily with a wide variety of people, including external partners, process team members and site management.
The candidate will be responsible for technical transfer, process validation, process stewardship and process monitoring, and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles is required to ensure those same standards are applied to the external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working.
The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.
Key Objectives/Deliverables
Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for gene therapy products.
Provide technical oversight and stewardship for manufacturing activities (e.g., tech transfer, process validation, frontline support and improvement).
Understand the scientific principles required for manufacturing drug substances, including stir-tank bioreactor, chromatography operation, TFF, viral filtration and aseptic processes.
Leads resolution of technical issues including those related to control strategy and manufacturing.
Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs.
Build and maintain relationships with development partners and central technical organizations.
Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation.
Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices.
Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents and annual reports.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Basic Requirements:
B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field; advanced degree preferred
3+ years of demonstrated experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering
Additional Preferences:
In depth knowledge and skills of the process of AAV cGMP manufacturing
Experience with AAV drug product formulation, fill and finish
Knowledge and experience with Regulatory requirements
Enthusiasm for changes, team spirit and flexibility
Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
Proficiency in delivering complex tasks and/or tasks that are cross-functional
Demonstrated Project Management skills and ability to coordinate complex projects
Experience with data trending and analysis
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 - $149,600
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.
WeAreLilly
