Director Aseptic Manufacturing

RESPONSIBILITIES: Direct and coordinate the cGMP aseptic compounding, sterilization technologies, inspection and aseptic filling functions at a new state-of-art facility. Direct staff in all aspects of the preparation, sterilization, aseptic processing and filling operations by following current GMPS and procedures. Direct the new aseptic filling facility activities to ensure a timely start-up. Ensure the operations are conducted in compliance by working with the quality organization to process the batch documentation in a timely manner, processing of deviations and change controls effectively, and implement corrective actions and preventative actions. Coordinate the production operations with multi-discipline team members. Manage the scheduling and planning aspects of the operation to ensure an on time delivery of the final product. Manage and develop the annual budget for the department.





REQUIREMENTS:BS / MS in chemical, mechanical engineering or other related scientific field with 15 to 20+ years of in the pharmaceutical parenteral manufacturing and or engineering fill finish experience under CGMP guidelines. At least 12 to 14 years of leadership and supervising a management and operation staff. Direct experience in CGMP aseptic processing and filling operations (with powder filling desirable). Direct experience in sterilization technologies. Demonstrated effective skills and competencies in Leadership and Teambuilding. Demonstrated experience to recruit and retain a motivated and effective team. Demonstrated ability to work with the Quality Organization, Process Engineering, Regulatory Affairs, Validation, and other Manufacturing groups. Experience with process analysis and cost effectiveness by employing Lean Manufacturing and/or Six Sigma technologies with effect monitoring and metrics program. Experience in working with FDA and other regulatory agencies. Experience with capital investment processes. Experience with effective safety and training programs. Knowledge with complex sterile bulk manufacturing operations. Knowledge in Programmable Logic Controllers (PLCs) processes. Knowledge in high speed labeling, carton operations, kitting and case packaging technologies, other secondary packaging materials, and terminal sterilization desirable. Strong verbal, technical writing and interpersonal skills; excellent decision making skills and teamwork skills; and outstanding organizational capabilities; team player; results and detail oriented; ability to promote change with positive results. PC Proficiency with Word documents, Excel spreadsheet analysis and other applicable data analysis tools. Knowledge of analytical test methodology and equipment desirable.


Management Recruiters of Wrightsville Beach (The Port City Group, Inc.) is an executive search and recruitment firm specializing in pharmaceutical and biotechnology industries. ALL RESUMES REMAIN CONFIDENTIAL. Qualified candidates, please send WORD resume, cover letter highlighting strengths for the position and daytime phone number to:
Amanda Troy