Job Description
Supports the Drug Product Manufacturing Sciences and Technology (DP MSAT) departments through monitoring process performance, data trending, data analysis and/or laboratory testing. Provides support for the design and development of drug product processes and will be part of a team responsible for industrialization, troubleshooting and validation of drug product processes at manufacturing sites, both international and domestic.A typical day might include, but is not limited to, the following: Performing verified data entry tasks into electronic systems in a timely and efficient mannerTracking cycle time and metrics for data entry processSupporting the implementation, expansion and continuous improvement of Regeneron’s Application for Data Aggregation and reporting systemManaging quality system events pertaining to data integrity and data management such as investigations, CAPAs, Change Controls and general document approvalsTracking trending process performance to establish/improve process capability, uses data analytics and/or laboratory testing to develop metrics and ensures process is operating within intended process control strategyAuthoring policies, technical reports/protocols, change controls, etc. in support of cGMP activitiesLeading efforts associated with the drug product Continued Process Verification (CPV), documentation and trending of In Process Control (IPC) initiativeMaintaining required training status on Regeneron specific work instructions and SOPsCollaborating with cross-functional teams to define and execute drug product process development and technology transfer activitiesCollaborating with peers, procures, implements and evaluates new technologies for potential future use in the drug product processMaintaining an awareness of relevant equipment and technology vendors, their existing and planned offerings and their anticipated performanceSupporting process investigations and assists with product impact assessment for change controls and internal/external investigations, through laboratory investigations and/or data analysisContinuously drives to improve processes for improved performance Travels up to 20%, as requiredThis role might be for you if:You have the ability to work independently or as part of a teamYou have the ability to communicate with transparency.You have experience working in complex and matrix environmentYou have Strong negotiation skills to reach consensus. Strong communication skills, both oral and writtenYou have Technical knowledge in drug product manufacturing, product development and validationTo be considered for this position you must have a BS/BA in engineering or scientific discipline. For an Associate Specialist we would require 0-2 years experience. Specialist level would require 2+ years experience with pharmaceutical/biologics cGMP environment. For Sr Specialist this level would require 5+ years experience within pharmaceutical/biologics cGMP environment. #J-18808-Ljbffr