Manager Production - Aseptic

Responsibilities

• Lead and develop production teams, including the direct supervision of supervisors, to achieve departmental objectives.
• Oversee daily manufacturing operations in aseptic and Grade C environments, ensuring compliance with cGMP, FDA, and EMA regulations.
• Maintain strict adherence to SOPs, cleanroom behavior, and contamination control practices.
• Partner cross-functionally with Quality Assurance, Engineering, and Supply Chain to ensure efficient production execution.
• Establish and monitor KPIs related to OEE, process efficiency, and quality.
• Drive continuous improvement and lean manufacturing initiatives to enhance operational excellence.
• Ensure audit readiness and serve as the manufacturing SME during regulatory inspections and internal audits.
• Coordinate investigations, deviation management, and CAPA implementation.
• Review and approve batch records, change controls, deviations, and work instructions.

Requirements

• Bachelor's degree in a scientific discipline or a related field.
• 5+ years of experience in pharmaceutical manufacturing.
• 3+ years of experience in production leadership roles.
• Deep expertise in aseptic processing, sterile filling operations, and cleanroom environments.
• Strong working knowledge of cGMP regulations.
• Proficiency in Microsoft Office (Excel, Word, Outlook).
• Ability to work shifts, including potential evenings and weekends.

About the Company

Tolmar is an innovative pharmaceutical company focused on developing and manufacturing specialty therapies for patients with unmet medical needs. Headquartered in Northern Colorado, Tolmar combines scientific rigor, operational excellence, and a collaborative culture to make a meaningful impact on patients and communities.