Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies Support internal... and external audits and inspections as a member of the audit/inspection team Perform additional duties as assigned by management...
: Participates in the day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment..., monitoring, and data flow metrics from the clinical sites, CROs and central labs Supports complex clinical trial activities...
The Senior Analyst will specifically support the gene therapy program pipeline including but not limited to technical... methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability. The Senior...
The Facilities Director is a high-impact leadership role responsible for designing, implementing, and managing... of building a facility operations program from the ground up—including preventative maintenance systems, engineering controls...
specialty physicians on the appropriate use of rare disease products through one-on-one meetings and group presentations... within assigned geography. Educate customers on the appropriate use, characteristics, and approved indications of products...
. Responsibilities: Execute GDP/ GMP and business processes in the scope of GD America's Hub with minimum supervision Manage outbound... training materials related to the GD America's Hub Develop and maintain applicable Standard Operating Procedures, Forms...
Our client is seeking a highly motivated Entry-Level Quality Control (QC) Analyst to join the Gene Therapy QC Bioassay... group. This is an excellent opportunity for recent graduates or individuals early in their careers to gain hands...
with strong tactical execution skills to support the DSCL organization within MCS/DPNIM. The ideal candidate brings 5+ years of clinical.... The ideal candidate is comfortable working in the background of complex supply chain activities—processing orders...
Responsibilities: Support master data activities and analysis related to the external contract manufacturing network...
Our client is seeking a Medical Publications Manager within the Medical Affairs team. This role manages the development... and execution of high-quality scientific publications across the product portfolio within established timelines, collaborates...