Website BS/BA; Aseptic production experience required
Ensure timely manufacturing of all liquid and lyophilized parenteral cGMP products using aseptic processing technology to deliver high quality sterile products to the pharmaceutical industry. Manage all support manufacturing activities during a shift for the sterile filling business unit. Oversee personnel and activities related to the production process.
Essential Duties and Responsibilities:
• Manage and coordinate personnel and room activities for assigned shift.
• Compile area specific shift information and line status data in a timely manner accurately conveying information to support groups and oncoming shift management team.
• Ensure compliance with cGMPs, corporate and site-specific policies, and procedures.
• Maintain and report metrics to evaluate performance of assigned production unit.
• Mentor, develop, and guide succession planning and cross-functional training of direct reports.
• Schedule adherence and material consumption rates relative to specific areas.
• Manage operational and preventive maintenance of area specific processing equipment.
• Report and investigate safety incidents and quality deviations.
• Become fluent in all functional areas and provide leadership in the absence of manager(s).
• Share resources with other production units as needed and when available.
• Lead and/or conduct investigations, document revisions, protocol creation, and CAPA projects.
• Other duties as assigned
Directly supervises from 4-15 employees in a production unit department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education and/or Experience:
B.S. in scientific or business field preferred
Minimum 3 years directly related experience in industry or equivalent combination of education and experience.
To apply for this job email your details to firstname.lastname@example.org