- AbbVie (North Chicago, IL)
- …Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral ... products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from clinical proof of concept through commercial… more
- Merck (Rahway, NJ)
- …Combination Product Working Groups on cross-functional teams at the highest-level CMC teams and governance. + Serve as key point-of-contact with potential ... external device designers, developers, and suppliers for selected device technology platforms. + Oversee and serve as an integrator of all device development activities including engineering design, engineering analysis and testing, medical device design… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC , Regulatory Affairs, Patient Safety and Pharmacovigilance to implement ... discovery and development toxicology strategies that enable the progression of optimized drug candidates. + When appropriate, take lead to develop plan and lead sub-team for investigative studies to support investigations on mechanisms of toxicity. + Serve as… more
- AbbVie (North Chicago, IL)
- …non-sterile drug products. The team comprises of Chemistry, Manufacturing, and Controls ( CMC ) leads and drug product leads focused on commercialization of pipeline ... products and technical support for on-market products. The team ensures product longevity and robustness by championing product/process improvements, technical transfers, investigation resolution, and serving as key technical representatives for… more
- Lilly (Indianapolis, IN)
- …experienced and creative candidates with experience in chemistry, manufacturing and control ( CMC ) of oligonucleotides to participate in a wide range of activities. ... needs across the rapidly evolving Lilly Genetic Medicines (LGM) portfolio. The scientist will collaborate with a growing team comprised of chemists, analysts, and… more
- Lilly (Indianapolis, IN)
- …is looking for creative candidates with experience in chemistry, manufacturing and control ( CMC ) of peptides and oligonucleotides to participate in a wide range of ... emerging synthetic needs across the rapidly evolving portfolio of medicines. The scientist will collaborate with a growing team comprised of chemists, analysts, and… more
- Sanofi Group (Cambridge, MA)
- …medicine, statistics, CMC , IA **Basic Qualifications:** + Medical doctor or doctor/ scientist + More than 5 years of clinical or scientific, or more than ... agreed clinical plans + Working in matrix with cross-functional R&D and CMC functions he/she ensures deliverables of preclinical, clinical and quality studies needed… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Senior Engineer or Scientist 2 of Process Analytics serves as the subject matter expert (SME) and provides technology transfer support, ... (CAPA) in response to deviations *Manages Chemistry, Manufacturing and Control ( CMC ) activities for development and manufacturing, including coordination and input… more
- AbbVie (South San Francisco, CA)
- …new methods and techniques in PK/PD field. Act as a lead PK scientist in his/her area of expertise and critically evaluate relevant Clinical Pharmacology, PK/PD ... functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Author scientific publications and present at… more
- System One (Park Ridge, NJ)
- …strategies aligned with corporate innovation and compliance goals. The Principal Scientist must demonstrate a high level of autonomy, demonstrating ownership, ... + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC + Strong knowledge of QbD principles and designing appropriate DOE studies to… more