efforts with the group. Authoring CMC sections for regulatory, technical reports, department-specific protocols and reports... groups. The ability to accurately and independently generate procedures, protocols, reports, and CMC section content...
This is an onsite position. Duties: Scientific writer will work closely with Purification group leaders and Subject... with matrix environment of Purification development and CMC Project management to teams to document process risk, characterization...
understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection. · Advanced applied... principles to a varied audience both in individual and group settings; basic presentation skills. Note...
patient experience. CMC Laboratory Assistant II, Full Time Day, Kennesaw Medical Office Primary Location Kennesaw, Georgia... your and an HR Representative will contact you. Description: Job Summary: A CMC Laboratory Assistant II is responsible for the...
of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection. - Advanced applied knowledge.... Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills...
Technology group (PD DST) at Amgen’s FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation... on process validation floor process support as required Provide support for regulatory filing, inspection, and other CMC...
laboratories for late-phase antibody-drug conjugate (ADC) development. The candidate will support CMC activities to enable filing...-related changes and support deviation/excursion management Serve as analytical representative on CMC team; work closely...
successful regulatory strategies and submissions in support of clinical trials. This position utilizes CMC technical knowledge to drive... to: Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions Takes...
on , , , and . Job Description AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco is seeking a highly motivated... activities within the Biologics Analytical Research and Development Group. Responsibilities: Act as a subject matter expert...
on , , , and . Job Description AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity... challenges. Represent the Biologics CMC Analytical Research and Development Group as a subject matter expert on cross functional...