Job Posting: Supervisor, Bulk Processing

      Indianapolis, IN


      Position Overview


      Individual is responsible for setting directions and priorities in the Formulation area. Interacts with other departments to prioritize activities which impact production, safety and site compliance. Implements and ensures all Exelead’s policies and procedures are being followed. Maintains department in a full state of cGMP, safety and environmental compliance by following all relevant Federal, State and local laws and regulations. Supplies medicine on schedule and at right cost to all customers. Ensures a continuous improvement culture is pervasive throughout.


      Major Position Activities & Responsibilities


      • Scheduling, assigning and directing the work of Bulk Manufacturing personnel.
      • Assurance of compliance with cGMPs and all regulatory requirements. Ensure all safety programs are fully executed.
      • Ensure there are no spills or releases to the environment. Monitor and optimize departmental goals.
      • Identify and implement improvement opportunities. Manage activities through floor presence.
      • Maintain high level of profitability while controlling labor, waste and overhead costs.
      • Ensure all operators are trained on bulk operations tasks.
      • Ensure all medicines are formulated with the highest quality mindset.
      • Ensure that the highest level of Sterility Assurance is maintained throughout the site.
      • Optimize employee performance by providing ongoing feedback and coaching, rewarding and
      • discipling employees as needed.
      • Interviewing and selecting of perspective employees.
      • Serve as liaison with various departments: QA, QC maintenance, engineering, validation, and logistics
      • Act as manager in absence of supervisor.
      • Supervise the cleaning and maintenance of assigned area.
      • Perform special projects and other assigned duties.
      • Perform batch review of documents prior to QA review.
      • Write and review Master Production and Control records, Standard Operating Procedures and other Quality documents


      Scope: Supervises 5-8 team members


      Background Qualifications


      • 4-year college degree in Engineering or Science.
      • Two to three years in Parenteral Manufacturing.
      • Experience in supervision preferably direct.
      • Essential knowledge of cGMPs.
      • Demonstrated written and verbal communications skills as well as computer literacy (e.g. Microsoft
      • Word, Excel and PowerPoint) are required.
      • Ability to write reports, procedures and manuals.
      • Ability to read, analyze and interpret technical documents.
      • Ability to understand, interpret and utilize data.
      • •Possess very good problem-solving skills.
      • Must be able to work in controlled areas.


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