- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Job Summary** The Director /Senior Director , CMC , Drug Product Development will lead formulation ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- Sumitomo Pharma (Indianapolis, IN)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience ... around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Lilly (Indianapolis, IN)
- …highly desirable. + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership ... of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the Antibody-Drug Conjugate… more
- Lilly (Indianapolis, IN)
- …sciences and experience in pharmaceutical development to enable clinical trials, regulatory submissions, and new product commercialization. This role offers the ... offering access to word-class capabilities for pharmaceutical development. As the Director of Analytical Chemistry for Antibody-Drug Conjugates, you will play a… more
- Lilly (Indianapolis, IN)
- …enable or advance drug development and manufacturing + Author/review sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for ... practices and concepts to a variety of scientific partners. Purpose The Executive Director will provide strategic and statistical leadership to all assets in the… more
- Lilly (Indianapolis, IN)
- …to support communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic leadership role within ... technical excellence, and fosters collaboration across development, manufacturing, and regulatory functions. **Key Responsibilities:** **Tech Transfer Leadership** + Lead… more
- Lilly (Indianapolis, IN)
- …+ Ensure process definition of critical parameters are in alignment with regulatory submission. + Ensure that each of the department and external partner ... operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards though appropriate oversight. Ensure inspection readiness at all times. +… more
- Lilly (Indianapolis, IN)
- …Operations, Medical, Regulatory ) and key business partners such as Tech@Lilly, CMC , Clinical Design & Delivery, Radioligand Therapy (RLT) to develop and deliver ... project plans that encompasses all project management knowledge areas (timeline, scope, risks, communications; budget where applicable) + Hold project teams accountable for achievement of key deliverables in alignment with the project plan and corporate… more