Process Lead I

The Process Lead participates in the manufacture of Leukocyte Interleukin, Injection (LI) under cGMP for clinical application, and facilities operations and maintenance. The Process Lead reports directly to the Supervisor of Manufacturing.Education & Experience:B.S. and 5+ years experience in related fieldSkills & Abilities:Understanding and awareness of current Good Manufacturing Practices (cGMP) and basic familiarity with FDA and EU GuidelinesAble to follow Standard Operating Procedures (SOP’s)Familiarity with MasterControl and associated requirements for creating and revising controlled documentsAble to follow Master Batch Record when performing LI manufacture process stepsAble to work in an ISO classified work environmentDemonstrates good aseptic technique and ability to work in a biological safety cabinetParticipate in required safety, GMP, and technical training sessionsCoordinate training of newly hired or existing staffProvide technical assistance to junior and new staffContact vendors regarding new supplies or changes to existing suppliesTroubleshoot minor problems that may occur during LI manufacture process in communication with managementResponsibilities include, but are not limited to:Participate in the manufacture of clinical LIUnder direction from the Manufacturing Supervisor, Manager or Director, assist in the coordination and delegation of activities of junior staff in a specific process areaProvide guidance to junior staff requiring process knowledge and experienceTroubleshoot minor problems with the manufacturing processPropose changes to methods, design, or equipmentCoordinate training of newly hired employees and current employees, if neededRequisition materials from warehouse needed for processing and for support workClean, sanitize and monitor equipment, as assignedTroubleshoot problems with equipmentDraft, revise and process various SOP’s and other related documentsAble to follow and complete Batch RecordReview completed Batch Records and forms prior to submission for compliance and accuracyAccurately and promptly complete timesheets / other required paperworkAttend and contribute to departmental and general staff meetingsWORK HOURS:Position is full time. Monday through Friday with occasional Saturday work required. Normal business hours are 8:00 AM to 5:00 PM. Occasional weekend and evening work will be required.LOCATION:Elkridge, MD.Please submit cv/resume and cover letter to careers@cel-sci.com. Reference the job title in the subject line of the email.

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