Erik U. Email & Phone Number

Rockville, Maryland, Us

• Serve as primary point of contact and first line representative for the Bulk Reagents Manufacturing group. Regularly communicate with Quality Assurance, Purchasing, Shipping, and other Operational departments.• Track, analayze, and report on production metrics on a quarterly basis for review by senior management and company ownership.• Create budgetary proposals for capital asset purchases to ensure that growing manufacturing demands can be met.• Interface directly with internal and external representatives for raw material and equipment needs.• Work creatively with internal engineers and process teams to address production difficulties, material shortages, and supply chain delays. Assess and qualify alternative suppliers for critical raw materials.• Lead document and product change control efforts as they relate to the Bulk Reagents’ product portfolio.• Model and emphasize 5S and operational excellence efforts for the continuous improvement of the Reagent Manufacturing teams.• Develop requirements documentation for equipment purchases. Support validation and site acceptance receipt of new equipment.

Rockville, Maryland, Us

• Supervise production of all biological and chemical reagents with three direct reports.• Reporting of production failures/deviations and management of Quality documentation, including filing of planned and unplanned Deviations, Non-Conforming Manterial Reports, internal audit findings.• On the floor troubleshooting of production equipment including operation of automated filling lines and mixers. Work closely with Manufacturing Engineers to elevate and address equipment failures.• Review production batch records for correctness and completeness.• Manage weekly production schedule, address material shortages and potential equipment usage conflicts. Coordinate assignment of work orders using Enterprise Resource Planning system, working collaboratively with Planning group to meet demand.• Monitor inventory levels of raw chemicals and manufacturing supplies for shortages that would impact production schedule. Interface with Purchasing regularly to reduce impact to deadlines.

Rockville, Maryland, Us

• Handled a 30% increase in production in 2017 without making any new hires by instituting process improvements to multiple production areas.• Senior technician within the Bulk Reagent Manufacturing group at MSD. Group is responsible for material formulations ranging from 1-1000L, production of lyophilized kit components, batch record completion, work order completion and all fill/finish tasks therein.• Subject matter expert for all small and large volume production and relevant equipment used in Bulk Reagent Manufacturing. This includes involvement in updating existing production documentation as well as being an author/collaborator for new documents required for product launches or those related to process improvement. • Establish a working environment that focuses on meeting production deadlines safely, ethically, on time and according to all approved production processes.• Perform risk analysis, recommend corrective actions, and execute approved corrective actions for deviations and non-conformances as technical lead.

Rockville, Maryland, Us

• Authored documentation for operation of Monobloc filler used in Bulk Reagent Manufacturing.• Involved in Performance and Operational Qualification of capital purchase machinery used in Bulk Reagent Manufacturing.• Regularly involved in new hire training across the majority of Operations at MSD.

Rockville, Maryland, Us

• Formulation and fill/finish of small (1-20L) and large (40-500L) batch size biological and chemical reagents. • Material handling for incoming raw material receipt and interdepartmental material transfer.

Bachelor Of Arts (B.A.), Philosophy

Education record