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Job Title: Advisor / Sr. Advisor - Manufacturing Science and Process Innovation - Peptide Drug Substance At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
Path/Level: R5 - R6 Job Profiles: Manufacturing-Manufacturing Process Development-R5, Manufacturing-Manufacturing Process Development-R6
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Position Brand Description: At Eli Lilly and Company, we unite caring with discovery to create medicines that make life better for people around the world. Our Central Technical Service Manufacturing Science (TSMS) group is committed to manufacturing science and embracing technologies, partnering with broad Manufacturing Organizations to accelerate launches, increase manufacturing capacity and resilience, and reach more patients faster. This Manufacturing Science and Process Innovation role in Central TSMS focuses on embracing cutting-edge technologies and process innovation to advance our manufacturing processes for peptide drug substance. This significantly contributes to continued improvement in increasing manufacturing capacity and supply resilience, reaching more patients faster with our increase product portfolio.
We are seeking a highly motivated, experienced, and agile process development Scientist/Engineer to join our Central TSMS team. The ideal candidate will play a pivotal role in driving process innovation and enhancing manufacturing science for peptide drug substance production and the exciting portfolio demands. This is a great opportunity to work collaboratively with cross-functional teams to evaluate and adopt new technologies to improve process efficiency, ensure product quality, advance our manufacturing capabilities, and make an impact to patients we serve.
Key Responsibilities: Manufacturing Science Expertise: - Technical expertise with deep knowledge of the processes to be implemented for peptide commercialization. Provide excellent technical support for successful tech transfer, implementation in plant sites, robust production, and problem-solving for process-related operation issues.
- Maintain a thorough understanding of the state-of-the-art manufacturing and regulatory requirements, process innovation, and the latest advancements in peptide manufacturing and incorporate these into technical agendas for Post Launch Optimization (PLO) and advancing manufacturing capabilities.
- Demonstrate learning agility and flexibility to quickly pivot and learn new technologies, and successfully support an expanding product portfolio beyond peptides with the increased complexity and their manufacturing processes.
Process Development & Innovation: - Lead TSMS technical projects either externally through technical oversight to business partners or internally (experimental design, process development, modeling/production data analysis) to ensure a robust execution of post-launch technical projects and its delivery; fully understand business needs, and develop critical technical agenda and ensure its delivery.
- Act as the process/ platform technical steward for all accountable products.
- Identify and evaluate process improvements to enhance efficiency, scalability, and quality in peptide production.
Collaboration and Regulatory Compliance: - Engage strongly with PRD on new products, processes, and platforms to ensure successful and streamline implementation of new processes.
- Collaborate with cross-functional teams, including Product Research and Development, quality assurance, and regulatory affairs, to enable the commercialization of the product and PLO technical agenda delivery and process change implementation.
- Ensure compliance with regulatory standards and internal policies related to process development and manufacturing.
- Prepare and review documentation for regulatory submissions and manufacturing protocols.
Qualifications / Basic Requirements: - Education: Ph.D. or Master's degree in Chemical Engineering, Biotechnology, Chemistry/Biochemistry, Pharmaceutical Sciences, or a related field.
- Experience: Strong background in process development and innovation within a product/process development or manufacturing environment
Additional Skills / Preferences: - Familiarity with cGMP regulations and quality management systems.
- Proficiency in analytical techniques relevant to peptide characterization and process optimization (HPLC, MS, etc.).
- Excellent problem-solving skills and ability to work under pressure in a fast-paced environment.
- Strong interpersonal and communication skills, with the ability to work collaboratively across teams.
Other Information: The role will support various products and their production sites in various locations (US and OUS). Travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible.
Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
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.
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Lilly may provide U.S. visa sponsorship for current employees who meet the basic qualifications of the role and, prior to applying, have confirmed U.S. visa feasibility with Lilly's U.S. Immigration Team. Roles on the B path, S path, or that do not minimally require a bachelor's degree are not feasible for visa sponsorship.
Lilly is proud to offer market-competitive employee benefits designed to empower you to live your best life. Employees may elect medical, prescription drug, dental and/or vision coverage for you and your family in one of two health plan options, enjoy best-in-class mental health support, and concierge services for orthopedic, cardiovascular, fertility care, and LGBTQ health navigation. We also support well-being with a fitness membership, health coaching, and wellness activities at no additional cost. Our retirement benefits are designed to help our employees feel secure in their financial future by including a defined benefit pension, a 401(k) match, and retiree medical coverage. We provide life and disability insurance for peace of mind and protection for you and your loved ones and paid time-off benefits to support you in life's moments that matter including personal illness, caregiver, bereavement, and other family needs, in addition to annual paid vacation and holidays. Lilly reserves the right to terminate or modify company provided benefits at any time in its discretion. The company compensation structures are aligned to the location of hire. The United States pay range and benefits offering do not apply to any location outside of the United States.
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