- Lilly (Indianapolis, IN)
- …of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the Antibody-Drug Conjugate ... to ensure manufacturability and facilitate smooth transition from early research to CMC development . + Develop scalable, robust, and reproducible processes for… more
- Lilly (Indianapolis, IN)
- …development cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected ... life better for people around the world. The Synthetic Molecule Design and Development (SMDD) is responsible for the development of synthetic drug substances… more
- Lilly (Indianapolis, IN)
- …novel technologies, innovative business relationships, and world class systems. The Senior Director , Strategic Alliances position seeks a collaborative, ... our world's greatest health challenges. In Product Research and Development (PRD), we transform molecules into medicines. Our portfolio...supply of material for toxicology and clinical trials. The Senior Director role will be critical to… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of… more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic ... across transfers. **Strategic & Portfolio Management** + Partner with CMC PMs and development teams to guide tech transfer execution using Lilly's Single… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Overview:** We are seeking a Senior Director , ADC Process Development , to lead and expand our growing ... CMC PM) and external CDMOs to align and execute the CMC development plan. + Create and update end-to-end capacity models, provide important data for… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Associate Director , Small Molecule Analytical Development ** + Lead and oversee phase appropriate method development and optimization for drug substance and ... and ensure compliance with applicable regulations and guidelines. + Provide CMC functional representation on wider cross-functional program development teams,… more
- Sumitomo Pharma (Indianapolis, IN)
- …to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on ... dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part… more
- Lilly (Indianapolis, IN)
- …sites. + Senior TS/MS management, Product and Technical leaders, development scientists, CMC PMs and molecule stewards. **Basic Requirements** + ... plan (BP), cGMPs and internal standards. + Escalate to Sr . Management in a timely fashion risks to supply,...of the team. + Support diversity in recruiting and development of team members. Lead recognition , merit… more