Aseptic Production Manager in Lenoir, NC at Apex Life Sciences

Date Posted: 6/4/2018

Job Snapshot

Job Description


Currently seeking an experienced Aseptic Production Manager to join a growing Pharmaceutical Company.

Please contact Leah Haas at 919.334.0373 or lhaas@apexlifesciences.com

Position Summary

The Operations Manager is responsible for overseeing and coordinating all aspects of: Compounding, Filling, Inspection and Packaging and Labeling operations to obtain optimum efficiency, safety, cGMP compliance and economy of operations. Direct reports include: Compounding Technical Supervisor, Filling Supervisor and Inspection/Packaging and Labeling Supervisor.

Job Responsibilities

  • Plans, develops, and implements organizational policies and goals related to all manufacturing operations.
  • Directs manufacturing activities of all responsible departments to include: Compounding, Filling, Inspection and Packaging and Labeling to effect operational efficiency, regulatory compliance, and safety on a daily basis.
  • Reviews daily activity to determine adjustments in operations required to support the daily production schedule to ensure there are no stock out or back order situations.
  • Direct communication with department heads and VP of Pharmaceutical Operations on a regular basis outlining current status of plant operations, and to review any policy, program or operation changes that need to be implemented.
  • Coordinates with VP of Operations to achieve the strategic goals of the company, then communicates and executes accordingly.
  • Chairs and participates in meetings as required to maintain overall plant effectiveness, compliance and safety.
  • Supports Operational Excellence improvements and change within the organization through the use of Lean Six Sigma principles.
  • Oversees implementation of the training and safety programs to ensure employees work in compliance with all company SOPs, policies, cGMPs and applicable safety and regulatory requirements.
  • Performs regular appraisal of work performance for direct reports and works with the Human Resources Department to ensure policies, benefits, and growth development plans are implemented as per company directives.
  • Tracks and manages departmental expenses throughout the year to insure spending is within annual budget requirements for areas of responsibility.

Education Requirements 

BA/BS in Technical or Manufacturing field and at least 5 years of direct multi-disciplinary manufacturing experience in the pharmaceutical or chemical industries Required, or equivalent combination of education and experience. Preferred experience would include sterile manufacturing.

Experience Requirements 

  • Ability to multi-task without undue stress or errors. Must be able to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. 
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.  Ability to compute rate, ratio, and percent and to draw and interpret graphs.  Ability to apply general math concepts to practical situations
  • Ability to solve practical problems and deal with a variety of situations where only limited standardization exists.  Ability to interpret a variety of instructions: written, oral, diagram, or schedule form.
  • Excellent understanding of Microsoft Office software.  
  • Ability to make decisions. Highly developed and effective interpersonal skills are required.
  • Must be able to read and write English, and must possess good written and verbal communication skills.