The Technical Services Senior Specialist has responsibility for leading the technical transfer of a clinical biologics drug substance transfer to site. The biologics facility will utilize single use systems for upstream cell culture processing, and a combination of single use and traditional stainless steel systems for downstream purification processing.
The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.
The position requires effective cross-functional working relationships with Manufacturing, Engineering, Facilities, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; interacting with Process Development and Analytical sciences for introduction of new products; and providing support for Regulatory submissions to ensure successful facility start up and process qualification.
Purpose: Oversees the laboratory quality control testing of in-process, stability, and final drug products. Responsibilities: Coordinates with members of Manufacturing,...Apply For This Job
Purpose: Responsible for the QC Raw Materials laboratory team. Has technical responsibility for all chemical aspects of QC testing. Responsibilities:...Apply For This Job
Purpose: The Controls Engineer will execute projects in a fast paced, multi-disciplined, cross-functional team environment. Responsibilities: Manage production and the...Apply For This Job
Purpose: The individual in this position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a...Apply For This Job
Purpose: Perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group. Provide technical support, guidance and supervision...Apply For This Job
Responsibilities Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition....Apply For This Job