- Novo Nordisk (Bloomington, IN)
- …writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product. Environmental Monitoring: Evaluates the ... to support of ICH stability studies to determine the stability of bulk drug substance and drug product. Release and In-Process: Analytical testing, data… more
- Gilead Sciences, Inc. (Foster City, CA)
- …related impurities, and the establishment of high throughput analytical testing capabilities for drug substance and drug product. Additionally, they will be ... talent + Accountable for: + Developing analytical control strategies for drug substance and drug product, ensuring patient-centric considerations are… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** This position is located within the drug substance - drug product interface organization in Ridgefield, CT, working to advance the development ... identified critical quality attributes. + Implements scale-up strategies for drug substance with a focus of process understanding, identification of critical… more
- Merck (Wilmington, DE)
- …and directing all activities involved in the manufacture and supply of biologics drug substance , drug product, warehouse operations, and analytical ... for a number of complex manufacturing processes that involves production of drug substance and drug product. Ensures all customer service goals are… more
- Amgen (Holly Springs, NC)
- …while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility ... The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but… more
- Gilead Sciences, Inc. (Foster City, CA)
- …long-range plans with respect to analytical control strategies and regulatory strategies for drug substance and drug product quality attributes across all ... FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance , drug product, and devices + Well-versed in analytical… more
- Lilly (Indianapolis, IN)
- …(QP) or Authorized Batch Release person for review and release of Raw Materials, Drug Substance , Drug Product, and/or Drug -Device Combination Products. ... Production Records and electronic review and disposition processes across materials, drug substance , drug product, device assembly, and packaging. +… more
- Cambrex High Point (Longmont, CO)
- …is a leading global contract development and manufacturing organization (CDMO) that provides drug substance , drug product, and analytical services across the ... + Independently designs and proposes new synthetic processes to produce the drug substance . + May act as process chemistry lead for customer projects. Identify… more
- AbbVie (North Chicago, IL)
- …Development opportunities. + Responsible for critical technical scientific evaluation of CMC drug substance , drug product, and device development information ... diligence & evaluation process. This requires assessment and integration of drug substance process, characterization of physical chemical properties, formulation… more
- Amgen (Thousand Oaks, CA)
- …In this vital role you will be part of Amgen's Process Development organization, Drug Substance Technologies - Synthetics (DSTS) plays a vital role in developing ... robust drug substance manufacturing processes to serve patients. Specifically, DSTS is an integrated organization of small molecule process chemists and… more