• LMS Administrator responsible to create and revise items, curricula, and user accounts. Record learning events, run searches and reports to report training compliance metrics.• Review & assist in creation of training presentations, online modules, other training materials• Manage and deliver pre-campaign training reviews of Manufacturing training assignments for each campaign run at Rockville• Develop and expand the training management strategy of the Quality Control teams

• Perform training needs assessment• Administer LMS system with focus on Manufacturing training management• Develop administrator user guides for LMS system• Author, Review and revise departmental Standard Operating Procedures & Training Plans

• Conduct training sessions in classroom and hands-on environments.• Coordinate and create the following manufacturing training materials: -e-learning modules -Training Plans for competency courses -Training Manuals for manufacturing processes and equipment • Manufacturing New Hire Training 4-week program: -Generate program schedule & coordinate cross-functional team participation -Deliver competency training courses & sessions on a variety of cGMP and Biomanufacturing topics• Coordinator for projects that involve multiple Manufacturing Teams. Consensus building and clear communication to all involved parties on status and next steps.• Communicate project status and best practice updates to Manufacturing and Quality departments• Coordinate and deliver “On The Job Trainer Skills” course.• Strong attention to detail while writing and reviewing training material, SOP and Batch Record content.• Create and deliver training materials for New Hire Boot Camp• Producer, Director, Editor, Videographer and talent for HGS promotional and technical videos

Initiate a training program for Manufacturing Operations departmentDevelop, build consensus and support new SOP and batch record formatsCreate Training Manuals for manufacturing equipmentCoordinate SOP consolidation project in Manufacturing Operations department

Involved in producing therapeutic proteins for Phase I/II clinical trials.Operation and maintenance of B.Braun 50L, 400L, 1600L bioreactor skids used in mammalian cell culture process.Operation and maintenance of B.Braun 50L, and 200L skids used in microbial fermentation process.Operation and maintenance of B.Braun 15L bioreactor and 100L skid used in mammalian cell culture process.Work closely with PD group during tech transfer of each new process.Safety representative for production area and member of Safety Committee.

Novel Protein Fermentation Dept.• Operation and maintenance of an ABEC 50L fermenter and two NBS 3L fermenters.• Involved in the planning of new lab area and ordering of new supplies and equipment.• Maintain fermentation spreadsheet tracking run results.• Develop and maintain communications with surrounding departments including Purification, Facilities, IT and EH&S.

Production and development of a live viral bio-therapeutic involved in phase I/II clinical trials.• Operation and development of a Pharmacia size-exclusion chromatography column use to purify clinical material.• Train new manufacturing associates on the inoculation, harvest and purification steps of the process

Managed all operations within mammalian cell culture aseptic manufacturing cleanroom suite.• Maintained cGMP compliance of the cleanroom facility.• Investigated and solved problems concerning the production facility and Quality Assurance audits.

Produced and developed, under cGMP regulations, a new product being manufactured for the treatment of brain tumors in Phase I/II/III clinical trials.• Operated under aseptic conditions in the cleanroom and followed detailed standard operating and manufacturing procedures.