- Fujifilm (Holly Springs, NC)
- …leading and executing Cleaning Validation (CV) activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 ... CV procedures to align with FUJIFILM Biotechnologies (FB) Large Scale Biologics platform operating principles and regulatory requirements * Ensures compliance with… more
- Parexel (Raleigh, NC)
- …**Qualifications** + BA/BS (3-5 yrs.) of relevant experience in analytical chemistry or biologics testing lab + MS (1-2 yrs.) of relevant experience in analytical ... chemistry or biologics testing lab **Required Skills and Experience** + Must...molecules or plate-based assay experience. + Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …quality and reliability of pharmaceutical products, including small molecules and biologics . **Job Description** + **Supplier Quality Execution** + Support the ... quality. + Strong knowledge of GMP regulations for small molecules and/or biologics . + Experience conducting audits and managing supplier documentation. + Strong… more
- Elevance Health (Durham, NC)
- …is planning and development of budget impact models for pipeline drugs, biologics , and gene therapies using medical and pharmacy claims data. This role ... clinical evidence related to the efficacy, safety, and attributes of drugs, biologics , and gene therapies. + Drug, biologic, and gene therapy pipeline monitoring… more
- J&J Family of Companies (Wilson, NC)
- …for providing engineering design and start-up of GMP large molecule biologics manufacturing facility systems, and equipment. Provide integrated equipment, utility, ... (2)+ years of process/plant engineering experience in GMP MFG large molecule biologics facilities. + The ability to lead and/or support multiple projects… more
- Amgen (Holly Springs, NC)
- …of the Process Development Drug Substance Technology group at Amgen's FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of ... a fundamental understanding of Downstream (Purification) Bioprocessing to support biologics technology transfer, process validation, and plant start-up + Support… more
- Astellas Pharma (Sanford, NC)
- …degree and 3-5+ years of experience in a QA function in a biologics manufacturing facility or equivalent experienced quality professionals with 10+ years relevant ... quality experience in a biologics manufacturing facility. + Strong understanding of FDA, EMA, and ICH regulations and guidelines, as well as industry best practices.… more
- Parexel (Raleigh, NC)
- …* Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus) * Support regulatory ... processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus! Skills & Attributes *… more
- Fujifilm (Holly Springs, NC)
- …and troubleshooting * Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections * Prior authorship of Chemistry, ... Manufacturing and Control (CMC) sections for regulatory findings **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** * Ability to discern audible cues _To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes… more
- Fujifilm (Holly Springs, NC)
- …and troubleshooting + Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections + Prior authorship of Chemistry, ... Manufacturing and Control (CMC) sections for regulatory findings **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** + Ability to discern audible cues _To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes… more