- Lilly (Indianapolis, IN)
- …team is looking for experienced and creative candidates with experience in chemistry , manufacturing and control (CMC) of oligonucleotides to participate in a wide ... + Possess fluent knowledge in modern synthetic organic and nucleic acid chemistry methods with the drive to challenge existing methods, define new manufacturing… more
- Lilly (Indianapolis, IN)
- …and demonstrated capability with utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges + Lead and/or supervise the ... ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications + Embrace diversity in thoughts,… 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 drug ... relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, including sample collection, storage conditions, and… more
- Lilly (Indianapolis, IN)
- …in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of biologics/antibodies. You will serve ... delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions. * Partner with… more
- Lilly (Indianapolis, IN)
- …trial medicines, while also reducing costs and environmental impact. The Senior Director , Process Translation and Execution is directly responsible for managing the ... hybrid and biologics operations with onsite lab capabilities. The Senior Director Process Translation & Execution will be responsible for providing technical,… more
- Lilly (Lebanon, IN)
- …startup into GMP manufacturing operations._ **Main Purpose and Objectives:** The Senior Director - Quality Control is part of the Senior Leadership Team of ... the Lilly Lebanon API site (LP1). The QC Senior Director provides administrative and technical leadership in the development, performance, and maintenance of the QC… more
- Lilly (Indianapolis, IN)
- …and controlling manufacturing processes. + Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. ... level and educational degree (see below). + Bachelor's Degree or Masters in Chemistry , Engineering, Pharmacy, or related science with minimum of 15-20 years of… more
- Lilly (Indianapolis, IN)
- …engineering, or a related field (advanced degree preferred). Fields of study include Chemistry , Pharmaceutics, Chemical Engineering, Analytical Sciences, ... medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral… more
- Lilly (Indianapolis, IN)
- …engineering, or a related field (advanced degree preferred). Fields of study include Chemistry , Pharmaceutics, Chemical Engineering, Analytical Sciences, ... medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC… more
- Lilly (Indianapolis, IN)
- …efficacy of our drug products. + Collaborate with formulation and analytical chemistry partners to perform mechanistic research and develop a robust understanding of ... packaging systems and delivery devices to mitigate risks in clinical studies and commercialization of new drug products development, achieving desirable clinical… more
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