Bioprocess Scientist - Process Translation and Execution Lilly Medicine Fou at Lilly

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Jul, 26

Salary

171600.0

Posted On

19 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bioprocess science, Technology transfer, cGMP manufacturing, Mammalian cell culture, Downstream purification, Process optimization, Scale-down studies, Root cause analysis, Technical writing, Analytical methods, HPLC, UPLC, Process troubleshooting, Data analysis, Cross-functional collaboration, Batch record creation

Industry

Pharmaceutical Manufacturing

Description

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 recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates (ADC, ARC, etc.) Through cross-functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies and aligns with corporate and Lilly Research Labs (LRL) goals, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success. In the Foundry Construction and Project Delivery/Startup Phase (2025 to 2028), roles will be ﬂuid and dynamic as we build a new organization, design and implement the necessary systems and business processes required to enable operational readiness, support the project delivery, and build the site culture. Success will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry transitions from design to startup and ultimately to steady-state operations and continuous improvement. This period presents a unique opportunity for learning, growth, and making a lasting impact. We are seeking passionate and agile bioprocess scientists to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life. Responsibilities In this role, the bioprocess scientist will be responsible for facilitating the transfer of biological processes, under appropriate supervisory guidance, from development laboratories to production operations. This enables the successful transition to early-phase cGMP manufacturing of API required for clinical trial supply. Actively involved in receiving process information from research and development labs and translating that into execution at production scale in collaboration with operations, process engineering, quality and health and safety groups. Ordering and staging raw materials. Collaborate in setting up analytical methods and analyzing analytical data to make fact-based decisions. Efficient with summarizing and presenting process results and challenges. Perform scale-down studies to ensure plant readiness and support evaluation of new technology at small-scale for process steps including upstream cell culture and downstream purification operations at the Lilly Medicine Foundry. Evaluate key raw materials to support process transfer and execution and confirm plant readiness. Maintain accurate lab notebooks with accurate descriptions of process steps, observations and results to support technical transfers into the production environment. Documentation: Author, review technical documents, including the process transfer plan, batch records, campaign summary reports, and deviation reports. Process improvement: Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures. Contribute to process troubleshooting and investigations by supporting process deviations, quality events, and non-conformances. Collaborate with teams to perform root cause analysis (RCA) and develop effective corrective and preventive actions (CAPAs). Basic Requirements: B.S. or M.S. in biological sciences, chemical engineering, or related field. 2+ years of experience in manufacturing environments involving large molecule API or drug substance is preferred. 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 Skills and Preferences Working knowledge of mammalian cell culture, primary recovery and purification unit operations and process optimization. Experience supporting multiple therapeutic modalities in addition to monoclonal antibodies, for example, antibody drug conjugate-related operations. Experience with development and scale-up of cell culture and purification process steps. Comfortable working with larger sized bioreactors and downstream-related equipment in a cGMP regulated production environment. Highly motivated, able to learn rapidly, and demonstrates strong attention to detail. Experience creating batch records and process execution according to those records. Ability to prioritize multiple activities and manage ambiguity. Experience with analyzing data from a variety of analytical techniques, for example, HPLC/UPLC, SEC, CEX, CE-SDS, LC-MS, etc. Demonstrated ability to drive projects and accept change. Communication skills: Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams Problem-solving skills: Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges. Ability to work cross-functionally across disciplines and levels with operations, process engineers, analytical chemists, safety and quality representatives. Other Information Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Limited domestic and international travel (< 5%) may be required for this role. Role requires ability to work in manufacturing and laboratory environments. 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. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Responsibilities

The bioprocess scientist facilitates the transfer of biological processes from development laboratories to cGMP production operations. They are responsible for process execution, documentation, troubleshooting, and implementing process improvements to support clinical trial supply.