- Amgen (Thousand Oaks, CA)
- …Attribute Sciences, Manufacturing and Clinical Supply, Digital Strategy & Capabilities, Drug Product Technologies, or Combination Product Operations. ... Advancement of Activity Assays for Key Residual Host Cell Proteins + ** Drug Product Technology -** Using Mass Spectrometry as an In-line Process Analytical Tool… more
- Amgen (Thousand Oaks, CA)
- … Drug Substance Technologies, Attribute Sciences, Manufacturing and Clinical Supply, Drug Product Technologies, or Combination Product Operations. The ... Advancement of Activity Assays for Key Residual Host Cell Proteins + ** Drug Product Technology -** Using Mass Spectrometry as an In-line Process Analytical Tool… more
- Sanofi Group (Morristown, NJ)
- …and IVD products, intended to be used alone or in combination with a drug product , leading regulatory efforts in the development and post-marketing stages. The ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...a globally diverse team supporting the medical device, combination product , digital health and in-vitro diagnostic (IVD) products within… more
- Sanofi Group (Cambridge, MA)
- …and standards (ISO, IEC) + Acts as a systems engineer for both new drug device combination product development and enhancement of existing platforms. Ensures ... seamless integration of all product elements including drug formulation, primary container, delivery device, manufacturing processes, testing, labelling and… more
- Lilly (Indianapolis, IN)
- …+ Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing and obtaining global product marketing ... to questions. Preferred Experiences and Skills + Experience in parenteral drug product development, commercialization or manufacturing + Demonstrated knowledge… more
- Lilly (Louisville, CO)
- …characterization, analytical methods, and formulation + Flow chemistry + Project management + Drug product design and performance + Drug product ... characterization, analytical methods, and formulation, + Flow chemistry, + Project management, + Drug product design and performance, or + Drug product … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …field with 10+ years of experience in the biopharmaceutical industry working in drug product development + Experienced in successfully leading and managing CMC ... they will empower decision making while serving as a product development expert to all relevant internal and external...providing day to day support for GMP manufacture of drug products at external CDMOs. + You will partner… more
- Astellas Pharma (South San Francisco, CA)
- …design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying ... to Information Requests from agencies. + For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and… more
- AbbVie (North Chicago, IL)
- …The PDS&T Parenterals/Eye Care group is seeking a motivated Scientist as a CMC drug product project lead, specifically for parenteral drug product ... parenteral DP from development scale up to clinical/commercial scale. + Support drug product manufacture at GMP facilities from clinical to PPQ and commercial… more
- Genentech (Oceanside, CA)
- … product owner for our commercial products, including our internal and external drug substance and drug product network, implementation of new ... role in leading a seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance… more