Associate Process Development Scientist

The incumbent will support the Technology Department in 3 key areas:

Record/document management ? the incumbent will be responsible implementing and maintaining a system for properly archiving/retrieving documents for the department.  These documents include laboratory notebooks, Process Transfer Documents, Process Development documents, Development reports, Test protocols and reports, batch production records etc.  The documents must be scanned to pdf format prior to archiving in a qualified facility.  Will be trained to be a document author so the incumbent can create and revise SOP?s through the Quality Document system.  The incumbent will be responsible for ordering blank laboratory notebooks and distributing them to requestors from all of R & D.

 

SAP Subject Matter Expert ? the incumbent will support toxicology lot and clinical lot manufacturing in the Clinical Manufacturing Facility (CMF) by creating process orders for lot production in CMF and at Contract manufacturing sites.  Will order supplies, etc in support of toxicological and clinical material manufacturing; will support lab operations by processing material requests as needed; and will be the primary SAP Subject Matter expert in Technology.


Training Documentation ? the incumbent will oversee the data entry for all TSRs into the OnTrack for Training System.  The incumbent may utilize several resources in the Technology Department to enter data.  The incumbent will be responsible for maintaining the department Training Matrices with the Performance Development Department.  The incumbent will be the primary liaison between Technology and the Performance Development department. The incumbent will be the Subject Matter Expert in Technology for training documentation.

 

The Incumbent will assist with compliance with the CAPA program by participating in investigations and entering data and information in the Trackwise system.  The incumbent will work with the electronic maintenance system and assist in activities to support the capital spending program and the expense budget. Additionally will work closely with Technology personnel, QO Development New Business Product Quality Management Performance Development, Materials Management, Bioanalytics, and Pathogen Safety.

 

BS with relevant experience in a relevant discipline: Chemical Engineering, Biomedical Engineering, etc., plus minimum of 2 years of production and/or Engineering experience in the biopharmaceutical industry. The education requirement may be substituted with a combination of both relevant education and work experience. Requires a good understanding of the cGMP and FDA regulations. Must have a working knowledge of documentation systems (i.e., BPRs, Validation Protocols, SOPs CSRs, Expense Budget, Work Order, Purchasing Systems). Requires good technical writing skills. Human Relations Interact in an environment with many outside departments such as Regulatory Affairs, QA, Engineering, Maintenance, Safety, Validation, cGMP, OSHA, FDA, Production Planning, Accounting, etc. This position requires a wide variety of technical people skills. This person will have to review engineering documents for accuracy and completeness. Must be able to write validation documents and be skilled in presenting data. Must be capable of providing input on the process for SOP and BPR development.

 

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