! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the... (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation...
Operations Specialist 1 owns recipe and master data governance for electronic batch record (EBR) execution and drives continuous..., interfaces, training, standard operation procedures [SOPs], change controls) for successful transfer. This role operates...
, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists.... This includes equipment preparation, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting...
all required paperwork/documents to comply with Federal Regulations and FDA Reports variance or deviations from standard procedures... Correctable 20/20 vision Ability to visually inspect small products and print Be able to sit at workstation for up to 50 minutes...
Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day... might include the following: Reviewing and approving batch records from Contract Manufacturing Organizations (CMO) manufacturing...
and strategic use cases. Beyond delivery, the Lead Software Engineer sets the standard for engineering excellence within the team... across the organization. Key Responsibilities Design, build, and maintain scalable data pipelines and data services (batch...
, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation... and optimization. Knowledge of and hands-on experience with analytical methods used for small molecules and biomolecules (RP-HPLC, SEC...
. Taking the initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols... and Standard Operating Procedures. Your responsibilities will encompass various tasks, including production, meticulous...
level technical support and vision, provide task leadership for a small team that supports both the infrastructures... education and work experience. Familiarity with scripting and automation tools, including batch scripts, PowerShell, automation...
and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions... in their assigned area, Small Molecule, Hybrid, or Biologics, and educates the team on the proper operation of the facility. This role...