Bioprocess Scientist (Downstream) - Advanced Therapies Manufacturing

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Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes 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:

Downstream Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture. The successful candidate will be required to build deep technical expertise in their area of responsibility (including in-depth knowledge of the science behind the molecule and the process), have strong working skills on the manufacturing equipment set and control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring and may play a role in by implementing new technologies and process improvements in the manufacturing environment.

Key Objectives/Deliverables

• Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for AAV and gene therapy products

• Provide technical support for internal and external TS/MS activities (e.g., tech transfer, process validation, investigation, process stewardship and improvement)

• Understand the scientific principles required for manufacturing AAV drug substances and products, and have extensive hands-on experience on chromatography operation, TFF, viral filtration and sterile filtration

• Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes

• Work as part of cross-functional teams, and establish partnerships with applicable functions, operations, and development to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team

• Be able to assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation

• Identify process improvements and participate in implementation of Lean manufacturing initiatives

• 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

• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda

• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability

• Serve as technical interface external to the Lebanon site

• Provide audit support, as needed

• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.

• 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

• 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• In depth knowledge of gene therapy manufacturing

• Experience with large scale AAV vector production using single use bioreactor systems

• Experience using solution filling equipment and/or isolator technology

• Experience with QC assays in line with product CQAs including variability

• Strong interpersonal and teamwork skills

• Strong self-management and organizational skills

• Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization

• Experience with data trending and analysis

• Ability to analyze complex data and solve problems

• Demonstrated successful membership/leadership of cross-functional teams

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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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