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Manufacturing Operations Manager

2 months ago

Shirley, New York, United States American Regent, Inc. Full time
About the Role:

We are seeking a highly skilled and experienced Manufacturing Operations Manager to join American Regent, Inc. as a key member of our manufacturing department. As a Production Supervisor, you will be responsible for overseeing the day-to-day operations of our commercial aseptic manufacturing processes.

Key Responsibilities:
  • Direct shop floor supervision, batch record execution, SOP training, and manufacturing investigation reports
  • Supervise daily manufacturing operations across departments and make staffing decisions
  • Schedule and direct production personnel to operate the production lines as per the schedule
  • Achieve production performance objectives by delivering quality products in a timely and cost-efficient manner
  • Prioritize and allocate resources to meet annual operating plan and budgetary commitments
  • Hire, train, and evaluate employees' job performance, working with subordinates to further their skills and development
  • Ensure accuracy and timeliness of all batch paperwork according to Good Documentation Practices
  • Oversee cleaning of production areas as per procedures and schedules
  • Monitor safety and take corrective actions to eliminate hazardous situations
  • Address and coordinate problems with relevant departments and bring quality issues to management attention
  • Conduct investigations of process deviations and compile technical documentation
  • Develop technical documents, including Standard Operating Procedures (SOPs), Product/Process Specification Documents (PPSs), Manufacturing batch records (MBRs), and production training records
  • Support employee feedback and developmental processes
  • Emphasize safety and quality commitments within the department
  • Investigate and resolve disciplinary issues, up to and including suspensions and terminations
Requirements:
  • Associate degree, B.A. or B.S degree preferred
  • Minimum 3 years of previous supervisory experience in a GMP regulated industry or 1 to 3 years of leadership experience
  • Experience in manufacturing, the pharmaceutical industry, or with GMP/FDA regulations is a plus
  • Aseptic manufacturing, Isolator technology, and cleanroom experience preferred
  • Strong oral and written communication skills
  • Strong time management, organizational, and project management skills
  • Experience writing, reviewing, and executing standard operating procedures preferred
  • Knowledge of MS Applications (Word/Excel/Outlook/Power Point)
  • Must be able to read documents in Standard English, such as Standard Operating Procedures, maintenance schedules, and operating manuals
  • Chemical handling, mathematical aptitude, and the ability to troubleshoot and perform minor repairs on manufacturing equipment is preferred
Physical Environment and Requirements:
  • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
  • Employee must be able to occasionally lift and/or move up to 50 pounds
Benefits:

American Regent, Inc. offers a competitive total rewards package, including healthcare, life insurance, profit sharing, paid time off, matching 401k, and a wide range of other benefits. We celebrate diversity and are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.